Maximum strength hydrocortisone cream cream

Active ingredient

Hydrocortisone, USP 1%

Purpose

Anti-itch

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, jewelry, detergents, cosmetics, psoriasis, seborrheic dermatitis, for external genital, feminine and anal itching, other uses of this product should be only under the advice and supervision of a doctor

Warnings

For external use only

Do not use

for external feminine itching 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 the eyes, do not begin the use of any other hydrocortisone product unless directed by a doctor, for external anal itching: do not use more than directed 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

symptoms last for more than 7 days, the condition gets worse, symptoms clear up and occur again in a few days, rectal bleeding occurs, consult doctor promptly

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

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, consult a doctor.

For external anal itching - Adults: when practical, clean the affected area with mild soap and warm water, rinse thoroughly, gently dry by patting or blotting with toilet tissue or a soft cloth before applicaion of this product.

Children under 12 years of age: consult a doctor.

Other information

Storage temperature: not to exceed 30 oC (86 oF). Protect from freezing.

Before using any medication, read all label directions. Keep carton, it contains important information.

Inactive ingredients

benzyl alcohol, ceteareth 20, cetearyl alcohol, cetyl palmitate, glycerin, isopropyl myristate, isostearyl neopentanoate, methylparaben, peg-40 stearate, purified water. May contain citric acid or sodium citrate solution to adjust pH.

Ingredients and appearance - Product information

Maximum strength hydrocortisone cream cream- Hydrocortisone cream

Product information

Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC: 0363-0638
Route of Administration Topical

Active Ingredient/Active Moiety

Ingredient Name Strength
Hydrocortisone ( UNII: WI4X0X7BPJ)( Hydrocortisone - UNII: WI4X0X7BPJ ) 1.02 gin 100 g

Inactive Ingredients

Ingredient Name Code
Water ( UNII: 059QF0KO0R)
Glycerin ( UNII: PDC6A3C0OX)
Cetostearyl alcohol ( UNII: 2DMT128M1S)
Cetyl palmitate ( UNII: 5ZA2S6B08X)
Isostearyl neopentanoate ( UNII: 411THY156Q)
Methylparaben ( UNII: A2I8C7HI9T)
Isopropyl myristate ( UNII: 0RE8K4LNJS)
Peg-40 stearate ( UNII: ECU18C66Q7)
Benzyl alcohol ( UNII: LKG8494WBH)
Polyoxyl 20 cetostearyl ether ( UNII: YRC528SWUY)

Product Characteristics

Color white

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
OTC monograph not final part348 USA

Labeler - Walgreens( 008965063)

Establishment

Name ID/FEI Business Operations
Walgreens 008965063 manufacture( 0363-0638)

Carton label

Tube label