MedPath

Allantoin

Generic Name
Allantoin
Brand Names
Allegra Cooling Relief Anti-itch, Anbesol Cold Sore Therapy, Mederma Advanced Scar
Drug Type
Small Molecule
Chemical Formula
C4H6N4O3
CAS Number
97-59-6
Unique Ingredient Identifier
344S277G0Z

Overview

Allantoin is a substance that is endogenous to the human body and also found as a normal component of human diets . In healthy human volunteers, the mean plasma concentration of allantoin is about 2-3 mg/l. During exercise, the plasma allantoin concentration rapidly increases about two fold and remains elevated . In human muscle, urate is oxidized to allantoin during such exercise . The concentration of allantoin in muscles increases from a resting value of about 5000 ug/kg to about 16000 ug/kg immediately after short-term exhaustive cycling exercise . More specifically, allantoin is a diureide of glyoxylic acid that is produced from uric acid. It is a major metabolic intermediate in most organisms. Allantoin is found in OTC cosmetic products and other commercial products such as oral hygiene products, in shampoos, lipsticks, anti-acne products, sun care products, and clarifying lotions . Allantoin has also demonstrated to ameliorate the wound healing process in some studies .

Indication

Allantoin is commonly applied in a variety of topical vehicles or applications such as cosmetic creams, toothpastes, mouthwashes, shampoos, lipsticks, anti-acne products, and lotions for the purpose of moisturizing skin, enhancing the smoothness of skin, stimulating the healing of wounds, and soothing irritated skin .

Associated Conditions

  • Scarring

Clinical Trials

Title
Posted
Study ID
Phase
Status
Sponsor
2024/11/29
Phase 1
Recruiting
2022/11/07
Phase 1
Active, not recruiting
2022/02/02
Phase 1
Active, not recruiting
2021/06/22
Phase 1
Active, not recruiting
2017/10/26
Phase 1
Completed
2017/01/02
Phase 2
Completed
David Oh
2016/04/07
Phase 1
Terminated
2016/03/15
Not Applicable
Completed
Suleymaniye Birth And Women's Health Education And Research Hospital
2016/02/01
Phase 3
Terminated
2015/03/10
Phase 3
Completed

FDA Drug Approvals

Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
Pharmaceutics Corporation
49430-053
TOPICAL
2 mg in 1 1
3/20/2015
RENU LABORATORIES, LLC
76348-720
TOPICAL
1.18 g in 118 mL
5/6/2025
Aidance Scientific, Inc, DBA Aidance Skincare & Topical Solutions
24909-034
TOPICAL
0.6 g in 100 g
5/23/2025
TAGRID LLC
85384-0007
TOPICAL
10 mg in 1 g
5/8/2025
N/A
50555-210
ORAL
0.05 g in 100 mL
5/14/2025
Reedfresh Co., LTD
85514-6538
TOPICAL
1 g in 100 g
4/28/2025
Carolina Cannabis Creations LLC
82876-224
TOPICAL
0.85 g in 118.76 g
9/2/2025
Puretek Corporation
59088-326
TOPICAL
22.5 mg in 1 g
5/7/2025
Alivio Medical Products, LLC
69512-020
TOPICAL
2 g in 100 g
4/13/2015
Patchwerx Labs
69329-011
TOPICAL
2 g in 100 g
5/28/2015

EMA Drug Approvals

Approved Product
Authorization Holder
Status
Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product
Manufacturer
Approval Number
Dosage Form
Strength
Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product
Company
Approval Number
Drug Type
Dosage Form
Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product
Registration No.
Company
Licence No.
Strength
Registration Date
ZINTOIN CREAM
N/A
N/A
N/A
5/31/1986
BETOCAINE CREAM
N/A
N/A
N/A
4/2/1990
ALOX CREAM
N/A
N/A
N/A
5/31/1986
CONTRACTUBEX OINT
N/A
N/A
N/A
6/4/1983
SKINDERM CREAM
N/A
N/A
N/A
9/19/1987

TGA Drug Approvals

Approved Product
ARTG ID
Sponsor
Registration Type
Status
Registration Date
MEDIPULV ANTISEPTIC POWDER topical dusting powder tube
16129
Pharmacare Laboratories Pty Ltd
Medicine
A
10/3/1991
APURA SKIN PREPARATION SKIN RELIEF CREAM tube
91426
Medicine
A
10/22/2002
APURA SKIN PREPARATIOIN BLEMISH CONTROL GEL tube
91428
Medicine
A
10/22/2002
APURA SKIN PREPARATION SCALP RELIEF SHAMPOO bottle
91422
Medicine
A
10/22/2002

Health Canada Drug Approvals

Approved Product
Company
DIN
Dosage Form
Strength
Market Date
ELTA DERMAL WOUND CLEANSER
swiss american products inc.
02231349
Lotion - Topical
2 %
N/A
ALPHOSYL LOTION
reed & carnrick, division of block drug company (canada) ltd.
00167800
Lotion - Topical
2 %
12/31/1958
W15883-CS
warner-lambert canada inc.
02240584
Ointment - Topical
1.5 %
N/A
VIONEX SKIN PROTECTANT CREAM
metrex research, llc
02245489
Cream - Topical
0.51 %
2/11/2002
OPTREX EYE DROPS
schering-plough healthcare products canada, a division of schering canada inc.
02236576
Drops - Ophthalmic
0.08 %
8/20/1998
MOISTURE EXTREME SPF 15
maybelline canada
02274701
Stick - Topical
0.6 %
7/31/2006
TEGRIN CREAM
block drug company (canada) ltd.
00067229
Cream - Topical
1.97 %
12/31/1963
NATURAL ICE HEALER
the mentholatum company of canada ltd
02242614
Ointment - Topical
1 %
10/1/2001
ELTA DERMAL GEL FOR WOUND DRESSING
swiss american products inc.
02231350
Gel - Topical
2 %
N/A
OPTREX EYE DROPS
knoll pharma inc.
02185482
Drops - Ophthalmic
0.08 %
12/31/1996

CIMA AEMPS Drug Approvals

Approved Product
Company
Registration Number
Pharmaceutical Form
Prescription Type
Status
No CIMA AEMPS (Spain) approvals found for this drug.

Philippines FDA Drug Approvals

Approved Product
Company
License Number
Dosage Form
Strength
Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product
Company
License Number
Dosage Form
Strength
Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product
Company
Registration Number
Dosage Form
Strength
Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name
MA Holder
MA Number
Pharmaceutical Form
Active Ingredient
Authorization Date
No UK EMC drug information found for this drug.

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