ANTIBACTERIAL HAND SANITIZER- alcohol solution 
Cosmuses Cosmetics (Ningbo) 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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Drug Fact

Active Ingredient(s)

Alcohol 62%

Purpose

Antiseptic

Use

To decrease the bacteria on the skin that could cause disease

Recommended for repeated use

Warnings

For external use only-Hands

Flammable. Keep away from heat and flame

Stop use and ask a doctor if skin irritation develops

When use this product, keep out of eyes. In case of contact with eyes, flush thoroughly with water. Avoid contact with broken skin.  Do not inhale or ingest

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

Directions

Wet hands thoroughly with products and allow to dry without wiping

For children under 6, use only under adult supervision

Not recommended for infants

Other information

Do not store above 105F

May discolor some fabrics

Harmful to wooden finishes and plastics

Inactive ingredients

Water, glycerin, propylene glycol, aloe barbadensis leaf extract, carbomer, triethanolamine, tocopheryl acetate

image description

ANTIBACTERIAL HAND SANITIZER 
alcohol solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82953-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL62 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX)  
TRICLOSAN (UNII: 4NM5039Y5X)  
WATER (UNII: 059QF0KO0R)  
CARBOMER 940 (UNII: 4Q93RCW27E)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
ALOE (UNII: V5VD430YW9)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:82953-001-0110 mL in 1 BOTTLE; Type 0: Not a Combination Product08/31/2022
2NDC:82953-001-0220 mL in 1 BOTTLE; Type 0: Not a Combination Product08/31/2022
3NDC:82953-001-0330 mL in 1 BOTTLE; Type 0: Not a Combination Product08/31/2022
4NDC:82953-001-0460 mL in 1 BOTTLE; Type 0: Not a Combination Product08/31/2022
5NDC:82953-001-05240 mL in 1 BOTTLE; Type 0: Not a Combination Product08/31/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A05/29/2020
Labeler - Cosmuses Cosmetics (Ningbo) Co., Ltd (725290934)
Establishment
NameAddressID/FEIBusiness Operations
Cosmuses Cosmetics (Ningbo) Co., Ltd725290934manufacture(82953-001)

Revised: 9/2022
Document Id: e79eda0c-c293-d877-e053-2995a90a4d77
Set id: 1ae5c268-1834-4ac2-931e-bb7fd0088cd2
Version: 1
Effective Time: 20220901
 
Cosmuses Cosmetics (Ningbo) Co., Ltd