HYDROCORTISONE- hydrocortisone cream cream

Hydrocortisone by

Drug Labeling and Warnings

Hydrocortisone by is a Otc medication manufactured, distributed, or labeled by McKesson, Ultra Seal Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Hydrocortisone Cream 1%

Active Ingredients (in each gram)

Hydrocortisone USP 10 mg

PURPOSE

Purpose

Antipruritic (Anti Itch)

INDICATIONS & USAGE

Indications:
For the temporary relief of itching associated with minor skin irritation and rashes due to eczema, insect bites, poison ivy, poison oak, poison sumac, soaps, detergents, cosmetics, jewelry, seborrheic dermatitis, psoriasis scrapes
For the temporary relief of external genital, feminine and anal itching
Other uses of this product should be only under the advice and supervision of a doctor

WARNINGS

Warnings:
For external use only

• Avoid contact with eyes
• Do not exceed the recommended daily dosage unless directed by a doctor
• Do no use for treatment of diaper rash
• In case of bleeding, consult a doctor promptly

Consult a doctor:

• Before use if you have a vaginal discharge (for external feminine itching)
• For external itching, do not exceed the recommended daily dosage or if bleeding occurs
• If condition worsens or if symptoms persist for more than 7 days or clear up and occur again within a few days discontinue use of this product

When using this product:

• Do not put this product into rectum by using fingers or any mechanical device or applicator

STOP USE

Do Not Use:

• With any other Hydrocortisone product unless you have consulted 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 1-800-222-1222

DOSAGE & ADMINISTRATION

Directions:

• For adults and children 2 years of age and older: apply externally 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, 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.
• Children under 12 years or age; for external anal itching, consult a doctor.

OTHER SAFETY INFORMATION

Other Information:

• Store at controlled room temperature 59* to 86*F (15* to 30*C)
• Avoid excessive heat and humidity
• Tamper Evident. Do not use if packet is torn, cut or opened

INACTIVE INGREDIENT

Inactive Ingredients:
Benzoic acid, chlorphenesin, citric acid, glycerin, glyceryl monostearate, methylparaben, mineral oil, petrolatum, phenoxyethanol, polysorbate 80, purified water, titanium dioxide, trisodium citrate.

QUESTIONS

Questions? Call 1-800-777-4908

PRINCIPAL DISPLAY PANEL

NDC: 68599-1182-2
Hydrocortisone Cream 1%
Maximum Strength
Effective itch and rash relief cream.
NET WEIGHT
0.9 g (0.03 oz)

MFR # 118-82464

PRINCIPAL DISPLAY PANEL

NDC: 68599-1182-2
McKesson
Hydrocortisone Cream 1%
Maximum Strength
NET WEIGHT
0.9 g (0.03 oz)
144 PACKS PER BOX
MFR # 118-82464

PRINCIPAL DISPLAY PANEL

NDC: 68599-1182-2
McKesson
Hydrocortisone Cream 1%
Maximum Strength
NET WEIGHT
0.9 g (0.03 oz)
144 PACKS PER BOX
12 BOXES PER CASE
MFR # 118-82464

INGREDIENTS AND APPEARANCE

HYDROCORTISONE 
hydrocortisone cream cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68599-1182
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
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
METHYLPARABEN (UNII: A2I8C7HI9T)
MINERAL OIL (UNII: T5L8T28FGP)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
BENZOIC ACID (UNII: 8SKN0B0MIM)
WATER (UNII: 059QF0KO0R)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
CHLORPHENESIN (UNII: I670DAL4SZ)
PETROLATUM (UNII: 4T6H12BN9U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68599-1182-2	0.9 g in 1 PACKET; Type 0: Not a Combination Product	03/14/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	03/13/2019

Labeler - McKesson (023904428)