Label: HYDROCORTISONE WITH ALOE MAXIMUM STRENGTH- hydrocortisone cream
-
Contains inactivated NDC Code(s)
NDC Code(s): 68071-3197-1 - Packager: NuCare Pharmaceuticals, Inc.
- This is a repackaged label.
- Source NDC Code(s): 0472-0339
- Category: HUMAN OTC DRUG LABEL
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 April 8, 2019
If you are a healthcare professional or from the pharmaceutical industry please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts
- Active ingredient
- Purpose
-
INDICATIONS & USAGE
Uses for the temporary relief of itching associated with minor skin irritations, inflammation, and rashes due to:
•eczema •insect bites •poison ivy •poison oak •poison sumac •soaps
•jewelry •detergents •cosmetics •psoriasis •seborrheic dermatitis• for external genital, feminine and anal itching •other uses of this product should be only under the advice and supervision of a doctor
- Warnings
- Do not use
- When using this product
- Stop use and ask doctor if
- KEEP OUT OF REACH OF CHILDREN
-
Directions
Adults and children 2 years of age and older • apply to affected area not more than 3 to 4 times daily
Children under 2 years of age • do not use, consult a doctor
For external anal itching
Adults: when practical, clean the affected area with mild soap and warm water, rinse thoroughly, gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product
Children under 12 years of age: consult a doctor - Other information
-
Inactive ingredients
aloe vera concentrate, cetyl alcohol, glyceryl stearate, isopropyl myristate, methylparaben, polyoxyl 40 stearate, polysorbate 60, propylene glycol, propylparaben, purified water, sorbic acid, sorbitan monostearate, stearyl alcohol, white wax. May contain citric acid or sodium citrate solution to adjust pH.
- Questions?
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
HYDROCORTISONE WITH ALOE MAXIMUM STRENGTH
hydrocortisone creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68071-3197(NDC:0472-0339) 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 g Inactive Ingredients Ingredient Name Strength ALOE VERA LEAF (UNII: ZY81Z83H0X) CETYL ALCOHOL (UNII: 936JST6JCN) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) METHYLPARABEN (UNII: A2I8C7HI9T) POLYOXYL 40 STEARATE (UNII: 13A4J4NH9I) POLYSORBATE 60 (UNII: CAL22UVI4M) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) PROPYLPARABEN (UNII: Z8IX2SC1OH) WATER (UNII: 059QF0KO0R) SORBIC ACID (UNII: X045WJ989B) SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X) STEARYL ALCOHOL (UNII: 2KR89I4H1Y) WHITE WAX (UNII: 7G1J5DA97F) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) SODIUM CITRATE (UNII: 1Q73Q2JULR) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68071-3197-1 1 g in 1 TUBE; Type 0: Not a Combination Product 06/14/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 07/08/1998 Labeler - NuCare Pharmaceuticals, Inc. (010632300) Establishment Name Address ID/FEI Business Operations NuCare Pharmaceuticals, Inc. 010632300 relabel(68071-3197)