Hydrocortisone Cream Maximum Strength - Select Brand

Hydrocortisone by

Drug Labeling and Warnings

Hydrocortisone by is a Otc medication manufactured, distributed, or labeled by Chain Drug Consortium, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

HYDROCORTISONE MAXIMUM STRENGTH- hydrocortisone cream 
Chain Drug Consortium, LLC

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Hydrocortisone Cream Maximum Strength - Select Brand

Drug Facts

Active ingredient

Hydrocortisone USP, 1%

Purpose

Anti-itch

Use

• temporarily relieves itching associated with minor skin irritations, inflammation, and rashes due to
  • eczema
  • psoriasis
  • insect bites
  • poison ivy, oak, sumac
  • detergent
  • jewelry
  • cosmetics
  • soaps seborrheic dermatitis

• temporarily relieves external anal and genital itching

• other uses of this product should be only under the advise 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

When using this product

• avoid contact with the eyes
• do not use more than directed unless directed 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
• do not begin the use of any other hydrocortisone product unless directed by a doctor
• rectal bleeding occurs

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Direction

• 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: consult a doctor
• for external anal and genital itching
  • adults: when practical, clean the affected area with mild soap and warm water; rinse thoroughly
  • gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product
  • apply to affected area not more than 3 to4 times daily
  • children under 12 years of age: consult a doctor

Other information

• store at 15º-30ºC (59º-86ºF). Protect from freezing.
• before using any medication, read all label directions. Keep carton, it contains important information.

Inactive ingredients

cetyl alcohol, citric acid*, glyceryl stearate, isopropyl myristate, methylparaben, polyoxyl 40 stearate, polysorbate 60, propylene glycol, propylparaben, purified water, sodium citrate solution*, sorbic acid, sorbitan monostearate, stearyl alcohol, white wax

Questions or comments?

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal display panel

COMPARE TO THE ACTIVE INGREDIENT IN MAXIMUM STRENGTH CORTIZONE 10®†

MAXIMUM STRENGTH

Hydrocortisone Cream USP, 1%

ANTI-ITCH CREAM

Relieves

Itches and Rashes

NET WT. OZ (g)

For the temporary relief of itching associated with minor skin irritations, inflammation and rashes

†This product is not manufactured or distributed by Chattem, Inc., distributor of Maximum Strength Cortizone 10®.

Distributed by:

Pharmacy Value Alliance, LLC

407 East Lancaster Avenue,

Wayne, PA 19087

Package label

PREMIER VALUE Maximum Strength Hydrocortisone Cream 1%

HYDROCORTISONE  MAXIMUM STRENGTH
hydrocortisone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68016-909
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ)	HYDROCORTISONE	1 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
CETYL ALCOHOL (UNII: 936JST6JCN)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
METHYLPARABEN (UNII: A2I8C7HI9T)
POLYOXYL STEARATE 40 (UNII: 13A4J4NH9I)
POLYSORBATE 60 (UNII: CAL22UVI4M)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
WATER (UNII: 059QF0KO0R)
SORBIC ACID (UNII: X045WJ989B)
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
WHITE WAX (UNII: 7G1J5DA97F)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68016-909-01	1 in 1 CARTON	05/07/2021	12/31/2025
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	05/07/2021	12/31/2025

Labeler - Chain Drug Consortium, LLC (101668460)

Revised: 6/2025

Document Id: c3809b34-2164-45de-ae7a-3d8d9c5e7ffb

34390-5

Set id: cca3f279-e84e-433c-bd58-8782484b1944

Version: 4

Effective Time: 20250625