Label: HYDROCORTISONE- hydrocortisone cream
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Contains inactivated NDC Code(s)
NDC Code(s): 67777-237-01 - Packager: Dynarex Corporation
- 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 March 15, 2011
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
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Uses:
For temporary relief of;
- minor skin irritations, inflammation and rashes due to
- eczema
- insect bites
- poison ivy
- poison oak
- poison sumac
- soaps
- detergents
- cosmetics
- jewelry
- seborrheic dermatitis
- psoriasis
- scrapes
and for external itching of;
- genital
- feminine and
- anal itching
- other uses of this product should be only under the advice and supervision of a doctor
- minor skin irritations, inflammation and rashes due to
- Warnings:
- Do not use:
- Stop use and ask a physician if:
- Keep out of reach of children
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Directions:
Adults and children over 2 years of age
- Apply evenly to affected area no more than 3 or 4 times daily.
- Do not use
- consult a physician
- When practical, cleanse the affected area with mild soap and warm water and rinse thoroughly
- Gently dry, patting and blotting with bathroom tissue or soft cloth before applying
- apply externally to the area up to 6 times daily or after each bowel movement
- Other information:
- Inactive ingredients:
- Indications and Usage
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
HYDROCORTISONE
hydrocortisone creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:67777-237 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE 1 g in 100 g Inactive Ingredients Ingredient Name Strength CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) GLYCERIN (UNII: PDC6A3C0OX) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) METHYLPARABEN (UNII: A2I8C7HI9T) PETROLATUM (UNII: 4T6H12BN9U) POLYSORBATE 80 (UNII: 6OZP39ZG8H) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SODIUM CITRATE (UNII: 1Q73Q2JULR) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) WATER (UNII: 059QF0KO0R) PROPYLPARABEN (UNII: Z8IX2SC1OH) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:67777-237-01 12 in 1 CASE 1 144 in 1 BOX 1 0.9 g in 1 PACKET Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part348 02/02/2010 Labeler - Dynarex Corporation (008124539) Registrant - Dynarex Corporation (008124539)