CLEAN AND HAND GEL- alcohol gel
MAP Company 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.

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74930-001_Clean and Hand Gel

Active ingredient

Ethyl alcohol 62%

Purpose

Antimicrobial

Use

Hand sanitizer to help reduce bacteria on the skin

Warnings

Flammable. Keep away from fire or flame.

For external use only

When using this product do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.

Stop use and ask a doctor if irritation or rash appears and lasts

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

Directions

Put nough produt in your palm to cover hands and rub hands together briskly until dry.
Children under 6 years of age should be supervised when using this product

Other information

Store below 110°F (43°C)
May discolor certain fabrics or surfaces

Inactive ingredients

Butylene Glycol, Water, Carbomer

Product Label

CLEAN AND HAND GEL
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:74930-001
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	0.62 g in 1 mL

Ingredient Name	Strength
Inactive Ingredients
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
WATER (UNII: 059QF0KO0R)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:74930-001-01	90 mL in 1 TUBE; Type 0: Not a Combination Product	04/16/2020
2	NDC:74930-001-02	300 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	04/16/2020
3	NDC:74930-001-03	500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	04/16/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	04/16/2020

Labeler - MAP Company Co., Ltd. (694091767)

Registrant - MAP Company Co., Ltd. (694091767)

Name	Address	ID/FEI	Business Operations
Establishment
Opseve KOREA Co.,Ltd.		690048629	manufacture(74930-001)