Label: HYDROCORTISONE cream
-
Contains inactivated NDC Code(s)
NDC Code(s): 50607-5802-1, 50607-5802-2 - Packager: B8 Sales, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph 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 April 2, 2010
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Drug Facts
- Active ingredient
- Purpose
-
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
- other uses of this product should be only under the advice and supervision of a doctor
- Warnings
- Ask a doctor before use:
-
When using this product
- avoid contact with eyes
- do not put this product into rectum or vagina by using fingers or any mechanical device or applicator
Do not use
- with any other Hydrocortisone product unless you have consulted a doctor • for feminine itching
KEEP OUT OF REACH OF CHILDREN.
If swallowed, get medical help or contact a Poison Control Center right away.
Directions
- for adults and children 2 years of age and older apply
to affected area 3 to 4 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
- Other information
- Inactive ingredients
- Principal Display Panel
-
INGREDIENTS AND APPEARANCE
HYDROCORTISONE
hydrocortisone creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50607-5802 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 Ethanol (UNII: 3K9958V90M) methylparaben (UNII: A2I8C7HI9T) mineral oil (UNII: T5L8T28FGP) paraffin (UNII: I9O0E3H2ZE) petrolatum (UNII: 4T6H12BN9U) propylparaben (UNII: Z8IX2SC1OH) water (UNII: 059QF0KO0R) white wax (UNII: 7G1J5DA97F) Product Characteristics Color white (white) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50607-5802-1 25 in 1 BOX 1 .9 g in 1 POUCH 2 NDC:50607-5802-2 144 in 1 BOX 2 .9 g in 1 POUCH Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part347 05/01/2010 Labeler - B8 Sales, Inc. (833208635)
