SCAR GEL- scar cream gel 
Guangzhou Meayon Biotechnology Co,.Ltd

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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75728-004
scar gel

Active Ingredient(s)

Allantoin 0.3%

Purpose

Skin Protectant

Use

Temporarily protects and helps relieve chapped or cracked skin.

Warnings

For external use only.

Do not use

/

do not get into eyes.

condition worsens symptoms last more than 7daysor clear up and occur again within a few days DO not use on.
deep or puncture wounds animal bites serious burns.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

condition worsens symptoms last more than 7daysor clear up and occur again within a few days DO not use on.

Other information

/

Inactive ingredients

CYCLOPENTASILOXANE
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER

HEXYLDECANOL
STEARIC ACID
BRASSICA CAMPESTRIS (RAPESEED) STEROLS
ARGANIA SPINOSA KERNEL OIL
TOCOPHERYL ACETATE
CERAMIDE 3
CERAMIDE 6 II
CHOLESTEROL
MADECASSOSIDE

Package Label - Principal Display Panel

75728-004-01 15 g in 1 BOTTLE

75728-004-01 15 g in 1 BOTTLE

75728-004-02 20 g in 1 BOTTLE

75728-004-02 20 g in 1 BOTTLE

75728-004-03 30 g in 1 BOTTLE

75728-004-03 30 g in 1 BOTTLE

SCAR GEL 
scar cream gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75728-004
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z) ALLANTOIN0.3 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
HEXYLDECANOL (UNII: 151Z7P1317)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
RAPESEED STEROL (UNII: B46B6DD20U)  
ARGAN OIL (UNII: 4V59G5UW9X)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
CERAMIDE 3 (UNII: 4370DF050B)  
CERAMIDE 6 II (UNII: F1X8L2B00J)  
CHOLESTEROL (UNII: 97C5T2UQ7J)  
MADECASSOSIDE (UNII: CQ2F5O6YIY)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:75728-004-0115 g in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
2NDC:75728-004-0330 g in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
3NDC:75728-004-0220 g in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34803/30/2020
Labeler - Guangzhou Meayon Biotechnology Co,.Ltd (554520941)
Establishment
NameAddressID/FEIBusiness Operations
Guangzhou Meayon Biotechnology Co,.Ltd554520941manufacture(75728-004)

Revised: 8/2022
Document Id: e6f87686-6229-5f8d-e053-2a95a90ab99f
Set id: bea7e59b-ac34-3955-e053-2995a90a5cd5
Version: 3
Effective Time: 20220824
 
Guangzhou Meayon Biotechnology Co,.Ltd