CALLICOS HAND GEL SANITIZER- 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.

----------

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. 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

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

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.

label

CALLICOS HAND GEL SANITIZER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76586-112
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL62 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76586-112-03500 mL in 1 BOTTLE; Type 0: Not a Combination Product07/07/2020
2NDC:76586-112-02100 mL in 1 BOTTLE; Type 0: Not a Combination Product07/07/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A07/07/2020
Labeler - HEALKINBIO CO. (694039685)
Establishment
NameAddressID/FEIBusiness Operations
HEALKINBIO CO.694039685manufacture(76586-112)

Revised: 8/2020
Document Id: ae23c004-1fba-18cb-e053-2a95a90a04b3
Set id: a9d74740-a14a-b33d-e053-2a95a90a5321
Version: 6
Effective Time: 20200830
 
HEALKINBIO CO.