Label: CALLICOS SAFE GOOD HAND GEL- alcohol gel
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Contains inactivated NDC Code(s)
NDC Code(s): 76586-107-01, 76586-107-02, 76586-107-03 - Packager: HEALKINBIO CO.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated June 4, 2020
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- Official Label (Printer Friendly)
- Active Ingredient(s)
- Purpose
- Use
- Warnings
- KEEP OUT OF REACH OF CHILDREN
- Directions
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
CALLICOS SAFE GOOD HAND GEL
alcohol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:76586-107 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 70 mL in 100 mL Inactive Ingredients Ingredient Name Strength 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) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 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 Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 06/04/2020 Labeler - HEALKINBIO CO. (694039685) Establishment Name Address ID/FEI Business Operations HEALKINBIO CO. 694039685 manufacture(76586-107)