HAND SANITIZER- hand sanitizer gel 
Xiamen Afgamarine 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.

----------

Afgamarine, Hand Sanitizer, Ethanol 75%, Gel

Active Ingredient(s)

Ethyl Alcohol 75% v/v. Purpose: Antimicrobial

Purpose

Antimicrobial.

Use

Recommended uses:

External use to help reduce bacteria on the skin.

Warnings

Cautions and Warning:

DANGER! Flammable warning. Keep away from open flame and sources of heat.
For external use only.

Do not use

Contraindications:

Do not use on children/infants less than 2 years of age (unless directed by a doctor/physician/health care practitioner/health care provider/health care profession).

When using this product avoid contact with eyes.

Stop use and ask/consult a doctor/physician/health care practitioner/health care provider/health care profession if irritation develops and lasts.

Keep out of reach of children. If swallowed, call a poison control center or get medical help right away.

Directions

Superise children when they use this product. For occasional and personal dosmetic use. Rub thoroughly into hands for at least 30 seconds. Allow to dry.

Other information

Security Package: Security feature is self-evident.

Waste disposal: The disposal of this product and container shall be in accordance with local/national regulations.

Inactive ingredients

Aqua, Glycerin, Carbomer, Parfum, Triethanolamine.

Package Label - Principal Display Panel

Label

HAND SANITIZER 
hand sanitizer gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77607-100
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL75 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX)  
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
WATER (UNII: 059QF0KO0R)  
DICHROSTACHYS CINEREA WHOLE (UNII: N27D64ME6P)  
TROLAMINE (UNII: 9O3K93S3TK)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:77607-100-0130 mL in 1 BOTTLE; Type 0: Not a Combination Product05/19/2020
2NDC:77607-100-0360 mL in 1 BOTTLE; Type 0: Not a Combination Product05/19/2020
3NDC:77607-100-05100 mL in 1 BOTTLE; Type 0: Not a Combination Product05/19/2020
4NDC:77607-100-08200 mL in 1 BOTTLE; Type 0: Not a Combination Product05/19/2020
5NDC:77607-100-09236 mL in 1 BOTTLE; Type 0: Not a Combination Product05/19/2020
6NDC:77607-100-12300 mL in 1 BOTTLE; Type 0: Not a Combination Product05/19/2020
7NDC:77607-100-15500 mL in 1 BOTTLE; Type 0: Not a Combination Product05/19/2020
8NDC:77607-100-19946 mL in 1 BOTTLE; Type 0: Not a Combination Product05/19/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A05/19/2020
Labeler - Xiamen Afgamarine Biotechnology Co., Ltd. (420485152)
Registrant - A03 Lab of BTS (548009541)
Establishment
NameAddressID/FEIBusiness Operations
Xiamen Afgamarine Biotechnology Co., Ltd.420485152manufacture(77607-100) , label(77607-100)

Revised: 5/2020
Document Id: a61881f7-832f-b943-e053-2995a90a883c
Set id: a61881f7-832e-b943-e053-2995a90a883c
Version: 1
Effective Time: 20200520
 
Xiamen Afgamarine Biotechnology Co., Ltd.