DEPENS PREMIUM HAND SANITIZER- ethanol gel
HEALKINBIO CO.

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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Active Ingredient(s)

Ethanol 62%

Purpose

Purpose: Antiseptic

Use

 Hand sanitizing to help reduce bacteria on the skin

Warnings

 For external use only.
 Flammable, keep away from fire or flame.
 When using this product, avoid contact with the eyes. In case of contact, rinse eyes thoroughly with water.
 Stop use and ask a doctor if irritation or redness appears and lasts.

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

Directions

 Take suitable amount of sanitizer in the hand. Wet thoroughly and rub hands together until dry

Other information

 Store in room temperature 0~30℃

 Period of Use: 36 Months after manufacturing date

 Manufacturing Date and No. Printed on bottle

Inactive ingredients

Water(Aqua), Carbomer, Triethanolamine, Polyoxyethylene Hydrogenated Caster Oil, Green Tea Extract, Aloe Extract, Tocopheryl Acetate, Fragrance(Parfum)

Package Label - Principal Display Panel

image description

DEPENS PREMIUM HAND SANITIZER
ethanol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:76586-001
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
alcohol (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	alcohol	62 mL in 100 mL

Ingredient Name	Strength
Inactive Ingredients
Water (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:76586-001-01	480 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/24/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	04/24/2020

Labeler - HEALKINBIO CO. (694039685)

Name	Address	ID/FEI	Business Operations
Establishment
HEALKINBIO CO.		694039685	manufacture(76586-001)