FDA Label for Equate Hydrocortisone

View Indications, Usage & Precautions

Equate Hydrocortisone Product Label

The following document was submitted to the FDA by the labeler of this product Walmart. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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Drug Facts

DISTRIBUTED BY: Walmart Inc.,
Bentonville, AR 72716


Active Ingredient



Hydrocortisone 1%


Purpose



Antipruritic (anti-itch)


Uses



  • temporarily relieves itching associated with minor skin irritations, inflammation, and rashes due to:
    • eczema
    • psoriasis
    • poison ivy, oak, sumac
    • insect bites
    • detergents
    • jewelry
    • cosmetics
    • soaps
    • 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

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 by using fingers or any mechanical device or applicator

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
  • rectal bleeding occurs

Otc - Pregnancy Or Breast Feeding



If pregnant or breast-feeding, ask a health professional before use.


Otc - Keep Out Of Reach Of Children



Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.


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, cleanse 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



  • store at 15 to 30°C (59 to 86°F)
  • Tamper Evident: DO NOT USE IF SEAL ON TUBE IS BROKEN OR MISSING.

Inactive Ingredients



aloe barbadensis leaf juice, ammonium acryloyldimethyltaurate/VP copolymer, bees wax, carbomer, ceteareth-6, cetyl alcohol, citric acid, coconut oil, corn starch, dimethicone, disodium EDTA, glycerin, isopropyl palmitate, methylparaben, mineral oil, propylene glycol, propylparaben, shea butter, sodium citrate, sodium lauryl sulfate, tocopheryl (vitamin E) acetate, white petrolatum, USP purified water


Questions Or Comments?



1-888-287-1915


Principal Display Panel - 28 G Tube Carton



NDC 79903-092-01

equate™

Compare to
Cortisone•10®
Intensive
Healing Formula
active
ingredient*

MAXIMUM STRENGTH

Hydrocortisone
Cream 1%
Intensive Healing
Formula

Antipruritic (Anti-Itch)
With Antioxidants

Relieves Itch Fast

* Please review the disclaimer below.