Label: HYDROCORTISONE- hydrocortisone, pramoxine hydrochloride spray
- NDC Code(s): 86069-120-04, 86069-120-08
- Packager: Stratford Care Usa, Inc.
- Category: OTC ANIMAL DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
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Drug Label Information
Updated November 22, 2022
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- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- INACTIVE INGREDIENT
- DOSAGE & ADMINISTRATION
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PRECAUTIONS
Cautions: For animal use only. For external use only. Avoid contact with eyes or mucous membranes. If eye contact occurs, rinse thoroughly with water and consult a veterinarian. If undue skin irritation develops or increases, discontinue use and consult a veterinarian. Keep out of the reach of children.
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INGREDIENTS AND APPEARANCE
HYDROCORTISONE
hydrocortisone, pramoxine hydrochloride sprayProduct Information Product Type OTC ANIMAL DRUG Item Code (Source) NDC:86069-120 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE 1 g in 100 mL PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056) PRAMOXINE HYDROCHLORIDE 0.5 g in 100 mL Inactive Ingredients Ingredient Name Strength PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) ALCOHOL (UNII: 3K9958V90M) GLYCERIN (UNII: PDC6A3C0OX) PEG-75 LANOLIN (UNII: 09179OX7TB) OAT (UNII: Z6J799EAJK) BENZYL ALCOHOL (UNII: LKG8494WBH) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:86069-120-04 118 mL in 1 BOTTLE, SPRAY 2 NDC:86069-120-08 237 mL in 1 BOTTLE, SPRAY Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 11/15/2021 Labeler - Stratford Care Usa, Inc. (036650469)