Label: RITE AID CALAMINE- calamine 8% and zinc oxide 8% lotion
- NDC Code(s): 11822-4352-9
- Packager: Rite Aid Corporation
- 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 June 23, 2022
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INGREDIENTS AND APPEARANCE
RITE AID CALAMINE
calamine 8% and zinc oxide 8% lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:11822-4352 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 XANTHAN GUM (UNII: TTV12P4NEE) CARRAGEENAN (UNII: 5C69YCD2YJ) BENTONITE (UNII: A3N5ZCN45C) 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:11822-4352-9 177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 11/13/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part347 03/25/1998 Labeler - Rite Aid Corporation (014578892) Registrant - Pharma Nobis, LLC (118564114) Establishment Name Address ID/FEI Business Operations Pharma Nobis, LLC 118564114 label(11822-4352) , manufacture(11822-4352) , analysis(11822-4352) , pack(11822-4352)