Allantoin (was jenny/lotioncrafter)

[Guest guest]

Hi Dolores,

You've discovered my weakness -- I'm a gadget queen. All of these tools are

ones that I have been using for a long time. It's fun to bring them to others.

Regarding allantoin, one of its most prolific uses is for the treatment or

prevention of dry, chapped skin and lips. ISP has an excellent brochure

regarding their Allantoin which I'm going to excerpt below. It should answer

most of your questions. There are even a couple of formulation included so you

can see how it is incorporated in both emulsions and anhydrous products.

This brochure by ISP is available at the following link:

http://www.ispcorp.com/products/hairskin/content/skincare/brochure/allantoin/all\

antoin.pdf

Allantoin

Category 1 Active Ingredient Skin Protectant

Allantoin has been classified by the Food and Drug Administration (FDA)

Over-the-Counter (OTC) Topical Analgesic Review Panel as a Category I (safe and

effective) active ingredient skin protectant. Allantoin has been widely used for

decades in cosmetic and OTC topical formulations because it is so effective. The

most popular applications are in the prevention and treatment of dry and chapped

skin and lips.

Soaps, detergents, acidic or alkaline materials, mechanical means or the

environment can irritate skin and lips. Allantoin helps alleviate and prevent

symptoms of irritated and dry skin, and dry and chapped lips. The U.S. Food and

Drug Administration in the Tentative Monograph, 48 Federal Register 6820-33

defines Allantoin as a skin protectant. A skin protectant is a drug which

protects injured or exposed skin or mucous membrane surfaces from harmful or

annoying stimuli. The FDA has approved the use of 0.5% to 2.0% Allantoin for

the:

Temporary protection of minor cuts, scrapes, burns and sunburns.

Prevention and temporary protection of chafed, chapped, cracked, or wind-burned

skin and lips.

Relief of dryness and softening of cold sores and fever blisters.

Treatment and prevention of diaper rash and to help protect/seal out wetness.

The FDA considers such explicit claims as drug claims. When 0.5% to 2.0%

Allantoin is added to cosmetic and personal care products and no claims are made

related to Allantoin, the product remains a cosmetic. The FDA does not recognize

Allantoin as a wound healing agent.

The most updated FDA regulations should be consulted since the above approved

uses are listed in the current tentative Final Monograph and may be modified

once the Final Monograph is published.

The benefits of Allantoin can be effectively used in:

Hand and body creams and lotions

Lipsticks and lip ointments

Shaving products

Sun and after-sun care products

Face and baby wipes

Baby and foot powders

Acne products

Anti-perspirants and deodorants

Diaper rash creams

Allantoin is also used in the topical pharmaceutical market in psoriasis

medications and analgesic gels. Allantoin has been used in various dental

preparations such as toothpastes and oral rinses.

Chemistry

Allantoin is a heterocyclic organic compound that conforms to the formula:

Chemical Names:

(2,5-Dioxo-4-Imidazolidinyl) Urea Glyoxylic Diureide Urea

(2,5-Dioxo-4-Imidazolidinyl)- 5-Ureidohydantoin

INCI Name: Allantoin

Allantoin is an amphoteric compound that is anionic under basic conditions.

Solubility data

SolventSolubility @25 °C (g/100g solvent)

Water 0.45g

Ethanol <0.1g

Methanol <0.1g

Propylene Glycol <0.1g

10% HCI <0.4g

10% NaOH 39.0g

Allantoin produces its desirable effects by promoting healthy skin. It is

postulated that Allantoin cleanses away necrotic tissue, speeding up the growth

of new, healthy tissue. Since Allantoin stimulates new and healthy tissue

growth, healing epithelization may take place.

Allantoin also has been described as a cell proliferant, an epithelization

stimulant and a chemical debrider in texts such as the United States

Dispensatory, Merck Index, and British Pharmaceutical Codex.

Regulatory Status

Allantoin is approved for use in the U.S. and in Europe.

CAS Number:97-59-6

EINECS Number:202-592-8

FDA Classification:Category I (safe and effective)

OTC Tentative Final Monograph

on Skin Protectant Drugs.

Allantoin is compatible with most ingredients used in personal care

formulations. Water solubility at monograph-approved levels is an issue.

Suspending the material in a thick base is the best way to resolve this issue.

When conducting stability testing, care must be taken to look for Allantoin

recrystallization.

Incorporation

To incorporate 0.5% Allantoin, or more, into an emulsion product, the emulsion

is made and Allantoin is added during the cooling process below 50 °C. Good

agitation is required to thoroughly disperse the Allantoin to achieve a suitable

suspension. Addition of Allantoin at 0.5% or more or at temperatures above 50 °C

in aqueous systems can cause solubilization and recrystallization upon cooling

into larger particles which are perceptible during product use.

Use levels

Recommended use levels: 0.5 - 2.0%

Formulations

TREATMENT STICK with PROLIPID® 151 and ALLANTOIN #10889-27-1

Ingredients %W/W Supplier

Phase A

Paraffin (Paraffin Wax 160/165) 9.50 B. Ross

Glyceryl Dilaurate (EMULSYNTTM GDL) 20.00 ISP

Petrolatum (Snow White Petrolatum) 63.60 Penreco

Glyceryl Stearate (and) Cetyl Alcohol (and) Stearyl Alcohol (and) Behenyl

Alcohol (and) Palmitic Acid (and) Stearic Acid (and) Hydroxyethyl

Cetearamidopropyldimonium Chloride (PROLIPID® 151) 5.00 ISP

Phase B

ALLANTOIN 1.00 ISP

Phase C

Isopropylparaben (and) Isobutylparaben (and) Butylparaben (LIQUAPAR® OIL)

0.40 ISP

Phase D

Silica (Cab-O-Sil M-5) 0.50 Cabot

----------

100.00%

Procedure

Melt Phase A ingredients; heat to 80 °C until melted and uniform. Maintain batch

at 80 °C. Add Phase B to batch; mix until uniform. Begin cooling batch to 75 °C.

Add Phase C to batch; mix until uniform. Add Phase D to batch; mix until

uniform. Pour samples at 75 °C.

Formulations

SKIN PROTECTANT BABY LOTION #10804-41-1

Ingredients %W/W Supplier

Phase A

Deionized Water 73.15

Glycerin 3.50

PVM/MA Decadiene Crosspolymer (STABILEZE® QM) 0.30 ISP

Phase B

Deionized Water 5.00

Sodium Hydroxide (10% Solution) 0.75 Fisher Scientific

Phase C

Beeswax (Yellow Beeswax NF Prills) 1.00 B. Ross

Ozokerite (Ozokerite Wax SP 1020P) 1.00 Strahl & Pitsch

Ethylhexyl Palmitate (CERAPHYL® 368) 4.00 ISP

Myristyl Myristate (CERAPHYL® 424) 3.00 ISP

Glyceryl Stearate (CERASYNT® SD) 0.50 ISP

Glyceryl Stearate (and) Laureth-23 (CERASYNT® 945) 1.30 ISP

PEG-20 Stearate (CERASYNT® 840) 0.70 ISP

Dimethicone (SI-TECTM DM 1000) 2.00 ISP

Phase D

Cyclopentasiloxane (SI-TECTMCM 040) 2.50 ISP

Phase E

Fragrance (#68665, LSR 17614) 0.20 Intarome

Propylene Glycol (and) olidinyl Urea (and) Iodopropynyl Butylcarbamate

(LIQUID GERMALL® PLUS) 0.60 ISP

ALLANTOIN 0.50 ISP

----------

100.00%

Procedure

Combine water and glycerin with mixing and then sprinkle in STABILEZE® QM. Heat

at 80 °C for at least 45 minutes. Combine Phase B and Phase C separately. Heat

Phase C to 75-80 °C with mixing. After heating Phase A for 45 minutes add Phase

B with mixing. As soon as Phase C heats to 75-80 °C add it to the batch with

mixing. Begin to cool the batch. Add Phase D at 55 °C with mixing. Add Phase E

at 35-30 °C in order listed, mixing between addition. QS for water loss and mix

to RT.

pH = 6.13

Viscosity = 26,000 cps

(Brookfield Model RVT, TB @ 5 RPM)

This formula has passed a 28-day double challenge efficacy test. However, the

preservative system has not been optimized to its lowest effective level.

HTH,

Welch

Lotioncrafter

http://lotioncrafter.com

Check out our new Diffuser Kits!

----- Original Message -----

From: dolores conrad

Sent: Friday, November 05, 2004 7:34 AM

your site is awesome for the home toiletries maker! Its a

godsend cause alot of the stuff you sell we were not able to get in

the past in small quanties. I love your explaination about being

tired of using that old iceteaspoon or reaching for the juice

glasses.......boy have I been there. I have a question about

allentoin.....I have heard it is healing on for skin how would that

do in a lip balm? Would it have any soothing effects on chapped wind

burned lips? thanks dolores