INSTANT HAND SANITISER- hand sanitizer gel

Instant Hand Sanitiser by

Drug Labeling and Warnings

Instant Hand Sanitiser by is a Otc medication manufactured, distributed, or labeled by Maxcare (Guangzhou) Cosmetics Co., Ltd., A03 Lab of BTS. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient(s)

Ethyl Alcohol 75% 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

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

Do not use

• on children less than 2 months of age
• on open skin wounds
• in the eyes. in case of contact, rinse eyes thoroughly with water

WHEN USING

When using this product keep out of eyes, ears, and mouth.

In case of contact with eyes, rinse eyes thoroughly with water.

STOP USE

Stop use and ask a doctor if irritation and redness develop and persist for more than 72 hours.

KEEP OUT OF REACH OF CHILDREN

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

Directions

• wet hands thoroughly with product briskly rub hands together until dry.
• children under 6 years of age should be supervised by an adult when using.

Other information

• Do not store above 105℉ (40.6℃)
• May discolor some fabrics
• Harmful to wood finishes and plastics

Inactive ingredients

Water, Glycerin, Carbomer, Triethanolamine.

Package Label - Principal Display Panel

INGREDIENTS AND APPEARANCE

INSTANT HAND SANITISER 
hand sanitizer gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75309-0105
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	375 mL  in 500 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
CARBOMER 940 (UNII: 4Q93RCW27E)
TROLAMINE (UNII: 9O3K93S3TK)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75309-0105-5	24 in 1 CARTON	04/21/2020
1	NDC: 75309-0105-1	500 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	04/21/2020

Labeler - Maxcare (Guangzhou) Cosmetics Co., Ltd. (550430165)

Registrant - A03 Lab of BTS (548009541)

Establishment
Name	Address	ID/FEI	Business Operations
Maxcare (Guangzhou) Cosmetics Co., Ltd.		550430165	label(75309-0105) , manufacture(75309-0105)