70% ALCOHOL/ALCOOL HAND SANITIZER- hand sanitizer gel

70% Alcohol/Alcool Hand Sanitizer by

Drug Labeling and Warnings

70% Alcohol/Alcool Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Sanrace Biotechnology Co., Ltd, A03 Lab of BTS. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

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, Propylene Glycol, Carbomer, Aloe Yohjyu Matsu Ekisu, Triethanolamine, Disodium Edta.

Package Label - Principal Display Panel

INGREDIENTS AND APPEARANCE

70% ALCOHOL/ALCOOL HAND SANITIZER 
hand sanitizer gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75448-011
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	38.5 mL  in 55 mL

Inactive Ingredients
Ingredient Name	Strength
ALOE (UNII: V5VD430YW9)
GLYCERIN (UNII: PDC6A3C0OX)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
CARBOMER 940 (UNII: 4Q93RCW27E)
TROLAMINE (UNII: 9O3K93S3TK)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75448-011-05	55 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/21/2020

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

Labeler - Sanrace Biotechnology Co., Ltd (543000938)

Registrant - A03 Lab of BTS (548009541)

Establishment
Name	Address	ID/FEI	Business Operations
Sanrace Biotechnology Co., Ltd		543000938	label(75448-011) , manufacture(75448-011)