Label: HYDROCORTISONE ULTRA STRENGTH- hydrocortisone cream
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Contains inactivated NDC Code(s)
NDC Code(s): 29500-2439-1 - Packager: Personal Care Products, 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 July 10, 2013
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredient
- Purpose
- Keep out of reach of children
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Uses
temporarily relieves itching associated with minor skin irritations, inflammation and rashes due to:
- eczema
- inset bites
- cosmetics
- psoriasis
- detergents
- soaps
- poison ivy, oak
- sumac
- jewelry
- seborrheic dermatitis
- temporarily relieves external anal and genital itching
- other uses of this product should only be under the advice and supervision of a doctor
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Warnings
For external use only
Do not use
- in the genital area if you have a vaginal discharge. Consult a doctor.
- for the treatment of diaper rash. Consult a doctor
When using this product
- avoid contact with eyes
- do not use more than directed unless told to do so by a doctor
- do not put directly into the rectum
Stop use and ask a doctor if
- condition worsens, symptoms persist for more than 7 days or clear up and occur again within a few days, and do not begin use of any other hydrocortisone product unless you have asked a doctor
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Directions
- for itching of skin irritation, inflammation, and rashes: 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: ask a doctor
- for external anal and genital itching: adults - when practical, clean the affected area with mild soap and warm water and rinse thoroughly - gently dry by patting or blotting with toilet tissue or a soft cloth before applying - apply to affected area not more than 3 to 4 times daily - children under 12 years of age: ask a doctor
- Other information
- Inactive ingredients
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Product Label
DRUGSTORE-Rx
SMART WELLNESS
Ultra Strength
Hydrocortisone Cream
Fast Itch and Rash relief
Helps relieve- Eczema
- Seborrheic dermatitis
- Psoriasis
- Poison ivy
- Poison oak
- Poison sumac
- Insect bites and more
NET WT. 0.5 OZ. (14 g)
Distributed by: PERSONAL CARE PRODUCTS, LLC Troy, Michigan 48084 U.S.A.
Code No.:MH/DRUGS/KD-313 Made in India
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INGREDIENTS AND APPEARANCE
HYDROCORTISONE ULTRA STRENGTH
hydrocortisone creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:29500-2439 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE 140 mg in 14 g Inactive Ingredients Ingredient Name Strength ALOE VERA LEAF (UNII: ZY81Z83H0X) POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY) CETYL ALCOHOL (UNII: 936JST6JCN) CETYL PALMITATE (UNII: 5ZA2S6B08X) GLYCERIN (UNII: PDC6A3C0OX) ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) ISODECYL NEOPENTANOATE (UNII: W60VYE24XC) METHYLPARABEN (UNII: A2I8C7HI9T) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:29500-2439-1 14 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 07/10/2013 Labeler - Personal Care Products, Inc. (966155082) Registrant - Personal Care Products, Inc. (966155082) Establishment Name Address ID/FEI Business Operations Anicare Pharmaceuticals Pvt. Ltd. 916837425 manufacture(29500-2439)