THERACARE HYDROCORTISONE CREAM- hydrocortisone cream

TheraCare Hydrocortisone Cream by

Drug Labeling and Warnings

TheraCare Hydrocortisone Cream by is a Otc medication manufactured, distributed, or labeled by Veridian Healthcare, Nantong Health & Beyond Hygienic Products Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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.
• for the treatment of diaper rash.
• with any other hydrocortisone product unless you have asked a doctor

When using this product

• use only as directed
• 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. (1-800-222-1222)

Directions

• for itching of skin irritation, inflammation, and rashes:
• adults and children 2 years of age and over: apply to affected area not more than 3 to 4 times daily
• children under 2 years of age: consult a physician
• for external anal and genital itching, adults and children 12 years of age and over:
  • 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: consult a physician

Other information

Store at 20-25C (68-77F)

do not use if tube seal under cap is broken

Inactive Ingredients

ceteareth-20, cetearyl alcohol, ethylhexylglycerin, glycerin, glyceryl 1-stearate, mineral oil, phenoxyethanol, water, white petrolatum

TheraCare Hydrocortisone Cream

INGREDIENTS AND APPEARANCE

THERACARE HYDROCORTISONE CREAM 
hydrocortisone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71101-220
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
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
GLYCERYL 1-STEARATE (UNII: 258491E1RZ)
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
MINERAL OIL (UNII: T5L8T28FGP)
WHITE PETROLATUM (UNII: B6E5W8RQJ4)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
PHENOXYETHANOL (UNII: HIE492ZZ3T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71101-220-01	1 in 1 CARTON	07/01/2023
1		28.3 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 Drug	M017	07/01/2023

Labeler - Veridian Healthcare (830437997)

Establishment
Name	Address	ID/FEI	Business Operations
Nantong Health & Beyond Hygienic Products Inc.		421280161	manufacture(71101-220)