TOPCARE HYDROCORTISONE INTENSIVE HEALING FORMULA- hydrocortisone cream

TopCare by

Drug Labeling and Warnings

TopCare by is a Otc medication manufactured, distributed, or labeled by Topco Associates LLC, Taro Pharmaceuticals U.S.A., Inc., Taro Pharmaceuticals Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

Hydrocortisone 1%

Purpose

Anti-itch

Uses

• temporarily relieves itching associated with minor skin irritations, inflammation, and rashes due to:
  • eczema
  • psoriasis
  • poison ivy, oak, sumac
  • insect bites
  • detergents
  • jewelry
  • cosmetics
  • soaps
  • seborrheic dermatitis
• temporarily relieves external anal and genital itching
• other uses of this product should only be under the advice and supervision of a doctor

Warnings

For external use only

Do not use

• in the genital area 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 eyes
• do not use more than directed unless told to do so by a doctor
• do not put directly into the rectum by using fingers or any mechanical device or applicator

Stop use and ask a doctor if

• condition worsens, symptoms persist for more than 7 days or clear up and occur again within a few days, and do not begin use of any other hydrocortisone product unless you have asked a doctor
• rectal bleeding occurs

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• for itching of skin irritation, inflammation, and rashes:
  • 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: ask a doctor
• for external anal and genital itching, adults:
  • when practical, clean 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 applying
  • apply to affected area not more than 3 to 4 times daily
  • children under 12 years of age: ask a doctor

Other information

• To open: unscrew cap, pull tab to remove foil seal, and screw cap back onto tube
• store between 20° to 25°C (68° to 77°F)
• 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?

Call 1-888-423-0139

SPL UNCLASSIFIED SECTION

DISTRIBUTED BY TOPCO ASSOCIATES LLC
ELK GROVE VILLAGE, IL 60007

PRINCIPAL DISPLAY PANEL - 28.4 g Tube Carton

TopCare
health™

MAXIMUM STRENGTH

OUR PHARMACISTS
RECOMMEND

NDC: 36800-099-02

Hydrocortisone 1% Cream

ANTIPRURITIC (ANTI-ITCH)

Intensive Healing Formula†

NET WT 1 OZ (28.4 g)

INGREDIENTS AND APPEARANCE

TOPCARE   HYDROCORTISONE INTENSIVE HEALING FORMULA
hydrocortisone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 36800-099
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
cetostearyl alcohol (UNII: 2DMT128M1S)
sodium lauryl sulfate (UNII: 368GB5141J)
sodium cetostearyl sulfate (UNII: 7ZBS06BH4B)
chamomile flower oil (UNII: 60F80Z61A9)
citric acid monohydrate (UNII: 2968PHW8QP)
corn oil (UNII: 8470G57WFM)
glycerin (UNII: PDC6A3C0OX)
glyceryl monostearate (UNII: 230OU9XXE4)
isopropyl palmitate (UNII: 8CRQ2TH63M)
maltodextrin (UNII: 7CVR7L4A2D)
methylparaben (UNII: A2I8C7HI9T)
mineral oil (UNII: T5L8T28FGP)
paraffin (UNII: I9O0E3H2ZE)
petrolatum (UNII: 4T6H12BN9U)
propylene glycol (UNII: 6DC9Q167V3)
propylparaben (UNII: Z8IX2SC1OH)
water (UNII: 059QF0KO0R)
stearyl alcohol (UNII: 2KR89I4H1Y)
vitamin A palmitate (UNII: 1D1K0N0VVC)
cholecalciferol (UNII: 1C6V77QF41)
.alpha.-tocopherol acetate (UNII: 9E8X80D2L0)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 36800-099-02	1 in 1 CARTON	08/23/1995
1		28.4 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part348	08/23/1995

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)