Label: CALPAK- alcohol gel
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Contains inactivated NDC Code(s)
NDC Code(s): 80543-001-01, 80543-001-02 - Packager: CALIFORNIA PAK INTERNATIONAL, INC
- Category: HUMAN OTC DRUG LABEL
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 September 30, 2020
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredient
- Purpose
- Use
- Warnings
- DO NOT USE
- WHEN USING
- KEEP OUT OF REACH OF CHILDREN
- Directions
- Other information
- Inactive ingredients
- Package Label - Principal Display Panel
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INGREDIENTS AND APPEARANCE
CALPAK
alcohol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:80543-001 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) CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO) ALOE VERA LEAF (UNII: ZY81Z83H0X) GLYCERIN (UNII: PDC6A3C0OX) ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) TROLAMINE (UNII: 9O3K93S3TK) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:80543-001-01 53 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 10/31/2020 2 NDC:80543-001-02 236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 10/31/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 10/31/2020 Labeler - CALIFORNIA PAK INTERNATIONAL, INC (615304953)