Label: CALAMINE- calamine 8% and zinc oxide 8% lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 45591-041-96 - Packager: Pierson Laboratories
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph 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 December 14, 2017
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- SPL UNCLASSIFIED SECTION
- Active Ingredients
- Purpose
- Uses
- Warnings
- When using this product
- Keep out of reach of children
- Directions
- Other information
- Inactive ingredients
- Label
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INGREDIENTS AND APPEARANCE
CALAMINE
calamine 8% and zinc oxide 8% lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:45591-041 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 160 mg in 1 mL Inactive Ingredients Ingredient Name Strength BENTONITE (UNII: A3N5ZCN45C) CARRAGEENAN (UNII: 5C69YCD2YJ) XANTHAN GUM (UNII: TTV12P4NEE) CALCIUM HYDROXIDE (UNII: PF5DZW74VN) GLYCERIN (UNII: PDC6A3C0OX) WATER (UNII: 059QF0KO0R) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:45591-041-96 177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 12/14/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part347 12/14/2017 Labeler - Pierson Laboratories (119184992) Registrant - Humco Holding Group, Inc. (825672884) Establishment Name Address ID/FEI Business Operations Humco Holding Group, Inc. 825672884 label(45591-041) , manufacture(45591-041) , analysis(45591-041) , pack(45591-041)