Hydrocortisone by AKRON PHARMA INC HYDROCORTISONE cream

Hydrocortisone by

Drug Labeling and Warnings

Hydrocortisone by is a Otc medication manufactured, distributed, or labeled by AKRON PHARMA INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Hydrocortisone 1%

Purpose

Anti-itch

Uses

temporarily relieves itching associated with minor skin irritations, inflammation and rashes due to:

• eczema
• insect bites
• poison ivy or sumac
• soaps
• detergents
• cosmetics
• jewelry,
• seborrheic dermatitis
• poison oak
• psoriasis
• temporarily relieves external anal and genital itching
• Other uses of this product should be undertaken only 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.
• for the treatment of diaper rash, Consult a doctor.

When using this product

• avoid contact with eyes
• do not use more thatn directed unless told to do so by a doctor
• do not put directly into the rectumby 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. Discontinue use of this product and do not begin use of any other hydrocortisone product unless you have consulted a doctor.
• rectal bleeding occurs.

Keep out of Reach of Children

If swallowed, get medical help or contact 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: ask a doctor

for external anal and genital itching, adults:

• 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 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 20-250C (68-770F).

Inactive Ingredients

aloe vera, benzyl alcohol, glyceryl monostearate, mineral oil, PEG-40, PEG-25, propylene glycol, purified water, squalane, stearic acid.

Questions or Comments?

Call toll-free 1-877-225-6999

SPL UNCLASSIFIED SECTION

Manufactured for:

Akron Pharma, Inc.
Fairfield, NJ 07004

www.akronpharma.com

Made in USA

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

HYDROCORTISONE 
hydrocortisone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71399-0180
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
BENZYL ALCOHOL (UNII: LKG8494WBH)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
MINERAL OIL (UNII: T5L8T28FGP)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
water (UNII: 059QF0KO0R)
SQUALANE (UNII: GW89575KF9)
STEARIC ACID (UNII: 4ELV7Z65AP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71399-0180-1	454 g in 1 JAR; Type 0: Not a Combination Product	09/13/2024
2	NDC: 71399-0180-2	1 in 1 CARTON	09/13/2024
2		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	09/13/2024

Labeler - AKRON PHARMA INC (067878881)