Hand Sanitizer by Xiamen Afgamarine Biotechnology Co., Ltd. / A03 Lab of BTS HAND SANITIZER gel

Hand Sanitizer by

Drug Labeling and Warnings

Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Xiamen Afgamarine Biotechnology Co., Ltd., A03 Lab of BTS. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

When using this product avoid contact with eyes.

STOP USE

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

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

INGREDIENTS AND APPEARANCE

HAND SANITIZER 
hand sanitizer gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 77607-100
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	75 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 77607-100-01	30 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/19/2020
2	NDC: 77607-100-03	60 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/19/2020
3	NDC: 77607-100-05	100 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/19/2020
4	NDC: 77607-100-08	200 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/19/2020
5	NDC: 77607-100-09	236 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/19/2020
6	NDC: 77607-100-12	300 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/19/2020
7	NDC: 77607-100-15	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/19/2020
8	NDC: 77607-100-19	946 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/19/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	05/19/2020

Labeler - Xiamen Afgamarine Biotechnology Co., Ltd. (420485152)

Registrant - A03 Lab of BTS (548009541)

Establishment
Name	Address	ID/FEI	Business Operations
Xiamen Afgamarine Biotechnology Co., Ltd.		420485152	manufacture(77607-100) , label(77607-100)