PERFECT SHIELD 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)

alcohol

Purpose

Water
Carbomer
Triethanolamine
Polysorbate 20
Butylene Glycol
Camellia Sinensis Leaf Extract
Tocopheryl Acetate
Fragrance

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

Water, Carbomer, Triethanolamine, Polysorbate 20, Butylene Glycolm, Camellia Sinensis Leaf Extract, Tocopheryl Acetate, Fragrance

label

PERFECT SHIELD HAND SANITIZER
ethanol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:76586-103
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	70 mL in 100 mL

Ingredient Name	Strength
Inactive Ingredients
TROLAMINE (UNII: 9O3K93S3TK)
CARBOMER 934 (UNII: Z135WT9208)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
WATER (UNII: 059QF0KO0R)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:76586-103-01	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/22/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	05/22/2020

Labeler - HEALKINBIO CO. (694039685)

Name	Address	ID/FEI	Business Operations
Establishment
HEALKINBIO CO.		694039685	manufacture(76586-103)