THE ORDINARY HAND SANITIZER- alcohol liquid 
Deciem Inc

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.

----------

This is a hand sanitizer

Active Ingredient(s)

Alcohol 70% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Use

Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Warnings

For external use only. Flammable. Keep away from heat or flame

Do not use

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Other information

Inactive ingredients

Aminomethyl Propanol, Carbomer, Carbomer, 934, Carbomer 940, Carbomer 941, Chlorphenesin, Denatonium benzoate, Isopropyl alcohol, Phenoxyethanol, Propanediol, Water

Package Label - Principal Display Panel

PDPPDP Peel to Reveal

THE ORDINARY HAND SANITIZER 
alcohol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72208-201
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
ISOPROPYL ALCOHOL (UNII: ND2M416302) 5 mL  in 100 mL
CARBOMER 934 (UNII: Z135WT9208) 0.7 mL  in 100 mL
AMINOMETHYL PROPANEDIOL (UNII: CZ7BU4QZJZ) 0.15 mL  in 100 mL
WATER (UNII: 059QF0KO0R)  
CHLORPHENESIN (UNII: I670DAL4SZ) 0.05 mL  in 100 mL
PHENOXYETHANOL (UNII: HIE492ZZ3T) 0.95 mL  in 100 mL
DENATONIUM BENZOATE (UNII: 4YK5Z54AT2) 0.049 mL  in 100 mL
PROPANEDIOL (UNII: 5965N8W85T) 3 mL  in 100 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72208-201-01240 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product03/30/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A03/30/2020
Labeler - Deciem Inc (203133665)
Establishment
NameAddressID/FEIBusiness Operations
CSR Cosmetic Solutions Inc.243501959manufacture(72208-201) , pack(72208-201)

Revised: 3/2020
Document Id: a2146172-5176-4bdb-e053-2995a90a416a
Set id: a23ba33a-2ce2-0514-e053-2a95a90a438b
Version: 1
Effective Time: 20200330
 
Deciem Inc