PURE CARE HAND SANITIZER- alcohol gel

Pure care hand sanitizer by

Drug Labeling and Warnings

Pure care hand sanitizer by is a Otc medication manufactured, distributed, or labeled by KINGKEY MBC LIFE TECHNOLOGY GROUP CO., LTD. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Alcohol 75% v/v.

Purpose

Antiseptic

Uses

Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Warnings

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

Do not use

• in children less than 2 months of age
• on open skin wounds

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

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

• Place enough product on hands to cover all surfaces. Rub hands together until dry.
• Supervise children under 6 years of age when using this product to avoid swallowing.

Other information

• Store between 59-860F (15-300C)
• Avoid freezing and excecssive heat above 1040F (400C)

Inactive ingredients

Package Label - Principal Display Panel

INGREDIENTS AND APPEARANCE

PURE CARE HAND SANITIZER 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73928-004
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
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73928-004-01	59 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/26/2020
2	NDC: 73928-004-02	148 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/26/2020
3	NDC: 73928-004-03	236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/26/2020
4	NDC: 73928-004-04	500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/26/2020
5	NDC: 73928-004-05	946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/26/2020
6	NDC: 73928-004-06	3785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/26/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	05/26/2020

Labeler - KINGKEY MBC LIFE TECHNOLOGY GROUP CO., LTD (545349263)

Establishment
Name	Address	ID/FEI	Business Operations
KINGKEY MBC LIFE TECHNOLOGY GROUP CO., LTD		545349263	manufacture(73928-004)