RxNorm Names
Review RxNorm Normal Forms
TOPCARE HYDROCORTISONE INTENSIVE HEALING FORMULA
(hydrocortisone)
cream
[Topco Associates LLC]
Permanent Link:
http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=7daafc44-e2a4-4f1b-bfca-3309a8e9a920| Category | DEA Schedule | Marketing Status |
|---|---|---|
| HUMAN OTC DRUG LABEL | OTC monograph not final |
NOTE: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.
Uses
- temporary relief of itching associated with minor skin irritations and rashes due to
- eczema
- insect bites
- poison ivy, poison oak, or poison sumac
- soaps
- detergents
- cosmetics
- jewelry
- seborrheic dermatitis
- psoriasis
- external genital 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
- in the eyes
- by putting this product into the rectum by using fingers or any mechanical device or applicator
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, 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: consult a doctor
Other information
- To open: unscrew cap, pull tab to remove foil seal, and screw cap back onto tube
- store at room temperature
- see carton or tube crimp for lot number and expiration date
Inactive ingredients
aloe barbadensis, cetearyl alcohol/sodium lauryl sulfate/sodium cetearyl sulfate, chamomile (anthemis nobilis) oil, citric acid, corn (zea mays) oil, glycerin, glyceryl stearate, isopropyl palmitate, maltodextrin, methylparaben, mineral oil, paraffin, petrolatum, propylene glycol, propylparaben, purified water, stearyl alcohol, vitamin A (retinyl palmitate), vitamin D (cholecalciferol), vitamin E (tocopheryl acetate).
| TOPCARE
HYDROCORTISONE INTENSIVE HEALING FORMULA
hydrocortisone cream |
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| Labeler - Topco Associates LLC (006935977) |
| Registrant - Taro Pharmaceuticals U.S.A., Inc. (145186370) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
| Taro Pharmaceuticals Inc. | 206263295 | MANUFACTURE(36800-099) | |
Revised: 01/2013
Document Id: cc4257fd-c315-41d9-b709-f32da2ce7f23
Set id: 7daafc44-e2a4-4f1b-bfca-3309a8e9a920
Version: 1
Effective Time: 20130108
Topco Associates LLC
