THERA PLUS MAXIMUM STRENGTH HYDROCORTISONE- hydrocortisone cream

Thera Plus Maximum Strength Hydrocortisone by

Drug Labeling and Warnings

Thera Plus Maximum Strength Hydrocortisone by is a Otc medication manufactured, distributed, or labeled by Fourstar Group USA, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 gential itching  other uses of this product should be under 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 persists 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 older: apply to affected area not more than 3 to 4 times daily  children under 2 years of age: do not use, 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 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

store at room temperature 68 °- 77° F (20°-25°C).

Inactive ingredients

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

Questions?

1-800-639-3803Weekdays 9 AM to 4 PM EST

Package Labeling:

INGREDIENTS AND APPEARANCE

THERA PLUS MAXIMUM STRENGTH HYDROCORTISONE 
hydrocortisone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80684-197
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
CETEARETH-20 (UNII: YRC528SWUY)
CETEARYL ALCOHOL (UNII: 2DMT128M1S)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL STEARATE (UNII: 230OU9XXE4)
MINERAL OIL (UNII: T5L8T28FGP)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
WATER (UNII: 059QF0KO0R)
WHITE PETROLATUM (UNII: B6E5W8RQJ4)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80684-197-00	6 in 1 BOX	11/20/2025
1		0.9 g in 1 PACKET; 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	11/20/2025

Labeler - Fourstar Group USA, Inc (140099503)

Registrant - Fourstar Group USA, Inc (140099503)