CALLICOS SAFE GOOD HAND GEL- alcohol 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

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

water glycerin carbome triethanolamine, tocopheryl acetate, Polysorbate 20, camellia sinensis leaf extract

label

CALLICOS SAFE GOOD HAND GEL
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:76586-107
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
WATER (UNII: 059QF0KO0R)
TROLAMINE (UNII: 9O3K93S3TK)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
GLYCERIN (UNII: PDC6A3C0OX)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
CARBOMER 940 (UNII: 4Q93RCW27E)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:76586-107-01	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/04/2020
2	NDC:76586-107-02	100 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/04/2020
3	NDC:76586-107-03	30 mL in 1 POUCH; Type 0: Not a Combination Product	06/04/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	06/04/2020

Labeler - HEALKINBIO CO. (694039685)

Name	Address	ID/FEI	Business Operations
Establishment
HEALKINBIO CO.		694039685	manufacture(76586-107)