Label: EQUATE HYDROCORTISONE- hydrocortisone cream
- NDC Code(s): 49035-541-16, 49035-541-64
- Packager: Wal-Mart Stores Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
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- Active ingredient
- temporarily relieves itching associated with minor skin irritations, inflammation, and rashes due to:
- poison ivy, oak, sumac
- insect bites
- seborrheic dermatitis
- external genital and anal itching
- other uses of this product should be only under the advice and supervision of a doctor
For external use only
Do not use
- for the treatment of diaper rash. Ask a doctor.
- for external genital itching if you have a vaginal discharge. Ask a doctor.
When using this product
- avoid contact with the eyes
- do not begin use of any other hydrocortisone product unless you have asked a doctor
- for external anal itching do not exceed the recommended daily dosage unless directed by a doctor. In case of bleeding, consult a doctor promptly.
- 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
- symptoms persist for more than 7 days or clear up and occur again within a few days
Keep out of reach of children.
If swallowed, get medical help or contact a Poison Control Center right away.
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. Ask a doctor.
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 a soft cloth before application of this product.
- children under 12 years of age with external anal itching: ask a doctor
- Other information
- store at 20°-25°C (68°-77°F)
- Inactive ingredients
aloe vera gel, ceteareth-20, cetearyl alcohol, cetyl palmitate, glycerin, isopropyl myristate, isostearyl neopentanoate, methylparaben, purified waterClose
- Questions or comments?
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Compare to Cortaid® Active Ingredient
Hydrocortisone 1% Cream
Relieves Itching and Redness Fast!
Helps heal rashes for healthier skin
Relieves Itches Due to:
Eczema, Insect Bites, Psoriasis, Rashes, Seborrheic Dermatitis, Poison Ivy, Oak, Sumac
Hydrocortisone 1% Cream Carton Image 1
Hydrocortisone 1% Cream Carton Image 2
- INGREDIENTS AND APPEARANCE
Product Information Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:49035-541 Route of Administration TOPICAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HYDROCORTISONE (HYDROCORTISONE) HYDROCORTISONE 1 g in 100 g Inactive Ingredients Ingredient Name Strength ALOE VERA LEAF POLYOXYL 20 CETOSTEARYL ETHER CETOSTEARYL ALCOHOL CETYL PALMITATE GLYCERIN ISOPROPYL MYRISTATE METHYLPARABEN WATER Product Characteristics Color WHITE Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49035-541-16 1 in 1 CARTON 1 56 g in 1 TUBE 2 NDC:49035-541-64 1 in 1 CARTON 2 28 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 06/29/2005 Labeler - Wal-Mart Stores Inc (051957769)