Label: HYDROCORTISONE MAXIMUM STRENGTH- hydrocortisone cream
- NDC Code(s): 70403-923-30
- Packager: Aru Pharma 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 May 15, 2023
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- Drug Facts
- Active ingredient
- Purpose
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Uses
• for temporary relief of itching associated with minor skin irritations and rashes due to: • Eczema • Insect bites • Soaps and detergents • Cosmetics • Jewelry • Seborrheic dermatitis • Psoriasis • Poison ivy, oak or sumac • For external genital, feminine and anal itching • Other uses of this product should be only under the advice and supervision of a doctor
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Warnings
For external use only
Do not use • In children under 2 years of age • If you have a vaginal discharge • For the treatment of diaper rash
Ask a doctor before use if you have • External genital or feminine itching • External anal itching • Bleeding
When using this product • Avoid contact with eyes • Do not exceed the recommended daily dosage unless directed by a doctor • Do not put this product into the rectum by using fingers or any mechanical device or applicator
Stop use and ask a doctor • If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, stop use and do not begin use of any other hydrocortisone product, unless you have consulted a doctor.
- KEEP OUT OF REACH OF CHILDREN
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Directions
For minor skin irritations and rashes, adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily. For external anal itching: • Adults: when practical, cleanse the affected area with mild soap and warm water and rinse thoroughly • Gently dry by patting or blotting with toilet tissue or soft cloth before application of this product • Children: under 12 years of age, consult a doctor.
- Inactive ingredients
- Other information
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- Packaging
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INGREDIENTS AND APPEARANCE
HYDROCORTISONE MAXIMUM STRENGTH
hydrocortisone creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70403-923 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE 10 mg in 1 g Inactive Ingredients Ingredient Name Strength CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) CETETH-20 (UNII: I835H2IHHX) PARAFFIN (UNII: I9O0E3H2ZE) MICROCRYSTALLINE WAX (UNII: XOF597Q3KY) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) LIGHT MINERAL OIL (UNII: N6K5787QVP) SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM (UNII: 3980JIH2SW) PROPYLPARABEN (UNII: Z8IX2SC1OH) METHYLPARABEN (UNII: A2I8C7HI9T) CHLOROCRESOL (UNII: 36W53O7109) WATER (UNII: 059QF0KO0R) Product Characteristics Color white (white to off white) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70403-923-30 1 in 1 CARTON 01/01/2018 03/31/2025 1 30 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 01/01/2018 03/31/2025 Labeler - Aru Pharma Inc. (079736192)