THERA PLUS ECZEMA HYDROCORTISONE ANTI ITCH- hydrocortisone cream

Thera Plus Eczema Hydrocortisone Anti Itch by

Drug Labeling and Warnings

Thera Plus Eczema Hydrocortisone Anti Itch 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 ingredients

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 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

aloe barbadensis leaf juice, cetyl alcohol, dimethicone, EDTA, ethylparaben, glycerin, glyceryl monostearate, isohexadecane, maltodextrin, methyl gluceth-20, methylparaben, petrolatum, phenoxyethanol, polysorbate 80, propylene glycol, sodium citrate, stearic acid, tocopherol, water, zingiber officinale (ginger) root extract

Questions?

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

Package Labeling:

INGREDIENTS AND APPEARANCE

THERA PLUS ECZEMA HYDROCORTISONE ANTI ITCH 
hydrocortisone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80684-146
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
ISOHEXADECANE (UNII: 918X1OUF1E)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
METHYLPARABEN (UNII: A2I8C7HI9T)
PETROLATUM (UNII: 4T6H12BN9U)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
STEARIC ACID (UNII: 4ELV7Z65AP)
TOCOPHEROL (UNII: R0ZB2556P8)
WATER (UNII: 059QF0KO0R)
GINGER (UNII: C5529G5JPQ)
METHYL GLUCETH-20 (UNII: J3QD0LD11P)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CETYL ALCOHOL (UNII: 936JST6JCN)
DIMETHICONE (UNII: 92RU3N3Y1O)
EDETIC ACID (UNII: 9G34HU7RV0)
ETHYLPARABEN (UNII: 14255EXE39)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80684-146-00	28 g in 1 TUBE; Type 0: Not a Combination Product	03/03/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	03/03/2025

Labeler - Fourstar Group USA, Inc. (140099503)