Label: HYDROCORTISONE cream
- NDC Code(s): 67060-370-09, 67060-370-39
- Packager: ADVANCED FIRST AID, 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 January 7, 2023
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- 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, detergents, cosmetics, jewelry,
seborrheic dermatitis, psoriasis and scrapes
• for external genital, feminine and anal itching • other uses of this product should be only under the
advice and supervision of a doctor
-
WARNINGS
Warnings:
• for external use only • do not use for the treatment of diaper rash
Consult a doctor: • before use if you have a vaginal discharge (for external feminine itching)
• for external itching, do not exceed the recommended daily dosage or if bleeding occurs
• If condition worsens or if symptoms persist for more than 7 days or clear up and occur again within
a few days
When using this product: • avoid contact with eyes • do not put this product into rectum by using
fingers or any mechanical device or applicator
Do Not Use: • with any other Hydrocortisone product unless you have consulted a doctor.
- KEEP OUT OF REACH OF CHILDREN
-
DOSAGE & ADMINISTRATION
Directions: • For adults and children 2 years of age and older: apply to affected area 1 to 2 times
daily. • Children under 2 years of age: do not use, consult a doctor. • Adults for external anal itching
when practical, cleanse the affected area with mild soap and warm water and rinse thoroughly or by
patting or blotting with an appropriate cleansing pad. • Gently dry by patting or blotting with toilet tissue or a
soft cloth before application of this product. • Children under 12 years of age: for external anal itching,
consult a doctor.
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
HYDROCORTISONE
hydrocortisone creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:67060-370 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 PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) GLYCERIN (UNII: PDC6A3C0OX) PETROLATUM (UNII: 4T6H12BN9U) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:67060-370-39 25 in 1 CARTON 04/08/2015 07/01/2024 1 NDC:67060-370-09 0.9 g in 1 PACKET; 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 04/08/2015 07/01/2024 Labeler - ADVANCED FIRST AID, INC. (114477180) Registrant - ADVANCED FIRST AID, INC. (114477180) Establishment Name Address ID/FEI Business Operations ULTRA SEAL CORPORATION 085752004 pack(67060-370) Establishment Name Address ID/FEI Business Operations ULTRA TAB LABORATORIES, INC. 151051757 manufacture(67060-370)
