Label: CALAMINE PLUS PRAMOXINE HCL- calamine plus spray aerosol, spray
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Contains inactivated NDC Code(s)
NDC Code(s): 42507-147-41 - Packager: HY-VEE, INC
- 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 December 22, 2017
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- Active ingredient
- Purpose
- Uses
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Warnings
For external use only. Use only as directed. Intentional misuse by deliberately concentrating and inhailing contents can be harmful or fatal.
When using this product
- do not get into eyes
- ask a doctor before using on children under 2 years of age
- Directions
- Other information
- Inactive ingredients
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INGREDIENTS AND APPEARANCE
CALAMINE PLUS PRAMOXINE HCL
calamine plus spray aerosol, sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:42507-147 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength FERRIC OXIDE RED (UNII: 1K09F3G675) (FERRIC OXIDE RED - UNII:1K09F3G675) FERRIC OXIDE RED 0.345 mg in 116 g ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 24.16 mg in 116 g PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056) PRAMOXINE HYDROCHLORIDE 2.72 mg in 116 g Inactive Ingredients Ingredient Name Strength BENZYL ALCOHOL (UNII: LKG8494WBH) CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) HYDRATED SILICA (UNII: Y6O7T4G8P9) ISOBUTANE (UNII: BXR49TP611) OLEYL ALCOHOL (UNII: 172F2WN8DV) ALCOHOL (UNII: 3K9958V90M) SORBITAN TRIOLEATE (UNII: QE6F49RPJ1) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:42507-147-41 116 g in 1 CANISTER; Type 0: Not a Combination Product 12/22/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 12/22/2017 Labeler - HY-VEE, INC (006925671)