THOMPSON HYDROCORTISONE 1%- hydrocortisone cream

Thompson Hydrocortisone 1% by

Drug Labeling and Warnings

Thompson Hydrocortisone 1% by is a Otc medication manufactured, distributed, or labeled by Thompson, Unifirst First Aid Corporation, Prestige Packaging, Medique Products. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredient

Hydrocortisone 1%

PURPOSE

Purose

Anti-itch

INDICATIONS & USAGE

Uses

• for the temporary relief of itching associated with minor skin irritations and rashes due to eczema, insect bites, poison ivy, poison oak, poison sumac, soaps, detergents, cosmetics, jewlry, seborrheic dermatitis, psoriasis and scrapes
• other uses of this product should be only under the advice and supervision of a doctor

WARNINGS

Warnings

For external use only

DO NOT USE

Do not use

• for the treatment of diaper rash
• in eyes
• for feminine itching

STOP USE

Stop use and ask a doctor if

• condition worsens or lasts more than 7 days, or clears and occurs again within a few days
• you begin use of any other Hydrocortisone product unless you have consulted a doctor
• bleeding occurs

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.

DOSAGE & ADMINISTRATION

Directions

• for adults and children 2 years of age and older: apply to the affected area 3 to 4 times daily
• children under 12 years of age: for external anal itching, consult a doctor
• children under 2 years of age: do not use, consult a doctor
• adults for external anal itching when practical, cleanse the affected area with mild soap and warm water and rinse thoroughly or by patting or blotting with appropriate cleansing pad
• gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product

OTHER SAFETY INFORMATION

Other information

• store at room temperature (do not freeze)
• tamper evident. do not use any opened or torn packets

INACTIVE INGREDIENT

Inactive ingredients

cetearyl alcohol*, ceteareth-20*, emulsifying wax*, ethanol*, ethylhexylglycerin*, glycerin*, glyceryl fatty acid ester*, methylpharaben*, mineral oil, paraffin*, petrolatum, phenoxyethanol*, propylparaben*, purified water, water*, white wax*

*may contain

QUESTIONS

Questions or comments? 877.506.4291

PRINCIPAL DISPLAY PANEL

Pull up and tear off to dispense

Hydrocortisone Cream 1%

Temporary Relief of Itching Associated with

Minor Skin Irritation and Rashes

Product CS93373 0.9 g (1/32 oz) Packets

25/Box

THOMPSON

Safety Works | Business Thrives™

INGREDIENTS AND APPEARANCE

THOMPSON HYDROCORTISONE 1% 
hydrocortisone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73408-937
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
ALCOHOL (UNII: 3K9958V90M)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
MINERAL OIL (UNII: T5L8T28FGP)
PARAFFIN (UNII: I9O0E3H2ZE)
PETROLATUM (UNII: 4T6H12BN9U)
WATER (UNII: 059QF0KO0R)
WHITE WAX (UNII: 7G1J5DA97F)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73408-937-73	25 in 1 BOX, UNIT-DOSE	03/15/2023
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	03/15/2023

THOMPSON HYDROCORTISONE 1% 
hydrocortisone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73408-981
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HYDROCORTISONE ACETATE (UNII: 3X7931PO74) (HYDROCORTISONE - UNII:WI4X0X7BPJ)	HYDROCORTISONE ACETATE	10 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
PETROLATUM (UNII: 4T6H12BN9U)
WATER (UNII: 059QF0KO0R)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
GLYCERIN (UNII: PDC6A3C0OX)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
MINERAL OIL (UNII: T5L8T28FGP)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73408-981-73	25 in 1 BOX	05/01/2023
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	05/01/2023

Labeler - Thompson (080998015)

Registrant - Unifirst First Aid Corporation (832947092)

Establishment
Name	Address	ID/FEI	Business Operations
Prestige Packaging		080667761	pack(73408-981, 73408-937)

Establishment
Name	Address	ID/FEI	Business Operations
Medique Products		086911794	pack(73408-981, 73408-937)