CALLICOS HAND GEL SANITIZER- alcohol gel

Callicos Hand Gel Sanitizer by

Drug Labeling and Warnings

Callicos Hand Gel Sanitizer by is a Otc medication manufactured, distributed, or labeled by HEALKINBIO CO.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

ethyl alcohol 62% v/v

Purpose

Antiseptic

Use

to decrease bacteria on the skin

recommended for repeated use

for use when soap and water are not available

Warnings

For external use only.
Flammable, keep away from fire or flame.

KEEP OUT OF REACH OF CHILDREN

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

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

INACTIVE INGREDIENT

water, carbomer, triethaqnolamine, peg-60 hydrogenated castor oil, camellia sinensis leaf extract, glycerin, tocopheryl acetate

WHEN USING

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.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CALLICOS HAND GEL SANITIZER 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76586-112
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
TROLAMINE (UNII: 9O3K93S3TK)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
CARBOMER 940 (UNII: 4Q93RCW27E)
GLYCERIN (UNII: PDC6A3C0OX)
PEG-60 HYDROGENATED CASTOR OIL (UNII: 02NG325BQG)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76586-112-03	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/07/2020
2	NDC: 76586-112-02	100 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/07/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	07/07/2020

Labeler - HEALKINBIO CO. (694039685)

Establishment
Name	Address	ID/FEI	Business Operations
HEALKINBIO CO.		694039685	manufacture(76586-112)