FDA Label for Topcare Hydrocortisone Plus 12 Moisturizers
View Indications, Usage & Precautions
- OTHER
- ACTIVE INGREDIENT
- PURPOSE
- USES
- WARNINGS
- DO NOT USE
- ASK A DOCTOR BEFORE USE IF YOU HAVE
- OTC - WHEN USING
- STOP USE AND ASK A DOCTOR IF
- OTC - KEEP OUT OF REACH OF CHILDREN
- DIRECTIONS
- FOR EXTERNAL ANAL ITCHING
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS?
- PRINCIPAL DISPLAY PANEL - 28.4 G TUBE CARTON
Topcare Hydrocortisone Plus 12 Moisturizers Product Label
The following document was submitted to the FDA by the labeler of this product Topco Associates Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Other
Drug Facts
DISTRIBUTED BY
TOPCO ASSOCIATES LLC
7711 GROSS POINT ROAD
SKOKIE, IL 60077
Active Ingredient
Hydrocortisone 1%
Purpose
Anti-itch cream
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
Ask A Doctor Before Use If You Have
- a vaginal discharge
- rectal bleeding
- diaper rash
Otc - When Using
When using this product consult a doctor before exceeding recommended dosage
Stop Use And Ask A Doctor If
- condition gets worse
- condition persists for more than 7 days
- condition clears up and occurs again within a few days. Do not begin to use any other hydrocortisone product unless you have consulted a doctor.
Otc - Keep Out Of Reach Of Children
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, 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).
Questions?
1-888-423-0139
[email protected]
Principal Display Panel - 28.4 G Tube Carton
TopCare®
MAXIMUM STRENGTH
Hydrocortisone 1%
Plus 12 Moisturizers
ANTIPRURITIC (ANTI-ITCH) CREAM
NET WT 1 OZ (28.4 g)
QUALITY
GUARANTEED
COMPARE TO
CORTIZONE•10® PLUS
active ingredient*
* Please review the disclaimer below.