MAXIMUM STRENGTH HYDROCORTISONE- hydrocortisone ointment

Maximum Strength Hydrocortisone by

Drug Labeling and Warnings

Maximum Strength Hydrocortisone by is a Otc medication manufactured, distributed, or labeled by DLC Laboratories, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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Drug Facts

Active ingredient

Hydrocortisone, USP 1%

Purpose

Antipruritic (Anti-itch)

Uses

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

Warnings

For external use only

Do not use

• for the treatment of diaper rash. Consult a doctor.
• for external feminine itching if you have a vaginal discharge. Consult a doctor.

When using this product

• avoid contact with the eyes
• do not use more than directed unless told to do so by a doctor
• do not put this product into rectum by using fingers or any mechanical device or applicator

Stop use and ask a doctor if

• condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days. Do not begin use of any other hydrocortisone product unless you have consulted a doctor.
• rectal bleeding occurs

KEEP OUT OF THE 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 times daily.

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
• gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product

Children under 12 years of age: for external anal itching, consult a doctor

Other information

• store at room temperature

Inactive ingredients

mineral oil, petrolatum

Questions

1-800-858-3889

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Distributed by:

De La Cruz Products
A Division of DLC Laboratories, Inc.
Paramount, CA 90723 USA

PRINCIPAL DISPLAY PANEL - 28 g Tube Box

De La Cruz®

Anti-Itch
Ointment

Maximum Strength

Hydrocortisone 1%

For Relief of Itching, Rashes
and Skin Irritations

• Fragrance Free
• Rapid Relief

Net Wt. 1 OZ (28g)

INGREDIENTS AND APPEARANCE

MAXIMUM STRENGTH HYDROCORTISONE 
hydrocortisone ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 24286-1560
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
MINERAL OIL (UNII: T5L8T28FGP)
PETROLATUM (UNII: 4T6H12BN9U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 24286-1560-1	1 in 1 BOX	03/22/2013
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 not final	part348	03/22/2013

Labeler - DLC Laboratories, Inc (093351930)