Label: HUMCO CALAGESIC- calamine and pramoxine hydrochloride lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 0395-9111-96 - Packager: Humco Holding Group, Inc.
- 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 19, 2020
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- Active Ingredients
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- Uses
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- Stop ue and ask a doctor if
- Keep out of reach of children.
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INGREDIENTS AND APPEARANCE
HUMCO CALAGESIC
calamine and pramoxine hydrochloride lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0395-9111 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 80 mg in 1 mL PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056) PRAMOXINE HYDROCHLORIDE 10 mg in 1 mL Inactive Ingredients Ingredient Name Strength CAMPHOR (NATURAL) (UNII: N20HL7Q941) DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4) GLYCERIN (UNII: PDC6A3C0OX) METHYLPARABEN (UNII: A2I8C7HI9T) POLYSORBATE 80 (UNII: 6OZP39ZG8H) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) PROPYLPARABEN (UNII: Z8IX2SC1OH) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0395-9111-96 177 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 - Humco Holding Group, Inc. (825672884) Registrant - Humco Holding Group, Inc. (825672884) Establishment Name Address ID/FEI Business Operations Humco Holding Group, Inc. 825672884 manufacture(0395-9111) , analysis(0395-9111) , pack(0395-9111) , label(0395-9111)