SKININC- alcohol gel 
Skininc Global Pte. 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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SKININC

Active Ingredients

Denatured Ethyl Alcohol 65% v/v

Purpose

Antimicrobial.

Warnings

Uses

Directions

Other Information 

Inactive Ingredient

Water,Mannitol,Acrylates/C10-30 Alkyl Acrylate Crosspolymer,Aminomethyl Propanol,Microcrystalline Cellulose,PEG-20 Sorbitan Cocoate,Carbomer,Disodium EDTA,Butylene Glycol,1,2-Hexanediol,Mentha Rotundifolia Leaf Extract,Mentha Piperita (Peppermint) Leaf Extract,Mentha Aquatica Leaf Extract,Cucurbita Pepo (Pumpkin) Fruit Extract,Perilla Frutescens Extract,Rheum Palmatum Root Extract,Angelica Gigas Extract,Cnidium Officinale Root Extract,Melaleuca Alternifolia (Tea Tree) Leaf Extract, Fragrance

Product Image

image description

SKININC 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80761-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL65 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
MANNITOL (UNII: 3OWL53L36A)  
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
MAGNESIUM DISODIUM EDTA (UNII: NDT563S5VZ)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
MENTHA X ROTUNDIFOLIA LEAF (UNII: K59TXG2L3U)  
MENTHA X PIPERITA WHOLE (UNII: 79M2M2UDA9)  
MENTHA AQUATICA LEAF (UNII: 5M106ME6PT)  
PUMPKIN (UNII: SYW0QUB89Y)  
RHEUM PALMATUM ROOT (UNII: G025DAL7CE)  
ANGELICA GIGAS ROOT (UNII: 32766B2FHX)  
CNIDIUM OFFICINALE ROOT (UNII: 8S3OZD358J)  
MELALEUCA ALTERNIFOLIA LEAF (UNII: G43C57162K)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:80761-001-0115 mL in 1 BOTTLE; Type 0: Not a Combination Product10/07/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A10/07/2020
Labeler - Skininc Global Pte. Ltd. (595292498)

Revised: 10/2020
Document Id: e1d41368-c726-4139-9648-cd9793211ced
Set id: 24b65720-fb5c-4d9d-a9c1-e07383fcc23e
Version: 1
Effective Time: 20201007
 
Skininc Global Pte. Ltd.