CVS HEALTH MAXIMUM STRENGTH HYDROCORTISONE- hydrocortisone ointment ointment

CVS Health Maximum Strength Hydrocortisone by

Drug Labeling and Warnings

CVS Health Maximum Strength Hydrocortisone by is a Otc medication manufactured, distributed, or labeled by CVS Health, Sheffield Pharmaceuticals LLC. 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 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

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.

Directions 

• adults and children 2 years of age and older: apply to affected area not more than 3 to 4 time daily
• children under 2 years of age: ask a doctor

for external anal itching,

• adults:when practical, clean the affected area with mild soap and warm water and rinse thoroughlygently 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 

• Store at a controlled room temperature 20-25°C ( 68-77°F)
• before using any medication read all label direction, keep carton it contains important information 

Inactive ingredient 

Petrolatum 

Questions? 1-800-222-1087

Principal Display Panel 

CVS              NDC: 51316-165-28    

Maximum strength

Cortisone Ointment 

Hydrocortisone 1%

NET WT 1.0 OZ  (28g)

INGREDIENTS AND APPEARANCE

CVS HEALTH MAXIMUM STRENGTH HYDROCORTISONE 
hydrocortisone ointment ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51316-165
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
PETROLATUM (UNII: 4T6H12BN9U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51316-165-28	1 in 1 CARTON	06/01/2024
1		28 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	06/01/2024

Labeler - CVS Health (062312574)

Registrant - Sheffield Pharmaceuticals LLC (151177797)

Establishment
Name	Address	ID/FEI	Business Operations
Sheffield Pharmaceuticals LLC		151177797	manufacture(51316-165) , analysis(51316-165)