Hydrocortisone by UniShield / Safetec of America, Inc. HYDROCORTISONE cream

Hydrocortisone by

Drug Labeling and Warnings

Hydrocortisone by is a Otc medication manufactured, distributed, or labeled by UniShield, Safetec of America, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Warnings

For external use only

Do not use

• in eyes
• for treatment of diaper rash

Stop use, as a doctor

• if condition worsens or lasts more than 7 days, or clears up and occurs again within a few days
• with use of other hydrocortisone products

Keep out of reach of children.

If ingested, contact a Poison Control Center right away

Directions

• apply to affected area not more than 3 to 4 times daily
• children under 2: ask a doctor

Inactive ingredients

Emulsifying wax, ethanol, methylparaben, mineral oil, paraffin, petrolatum, propylparaben, purified water, white wax

ACTIVE INGREDIENT

Hydrocortisone 1.0%

USES:

For temporary relief of itching associated with minor skin irritations, inflammation or rashes. Other uses of product should be only under the advice and supervision of a doctor.

PRINCIPLE DISPLAY PANEL

HYDROCORTISONE CREAM

1/32 oz. (0.9g)

Dist by:UniShield

San Fernando, CA 91340

ACTIVE INGREDIENT

Hydrocortisone 1.0%

USES: For temporary relief

of itching associated with

minor skin irritations, inflammation or rashes.

Other uses of product

should be only under

the advice and supervision

of a doctor.

INGREDIENTS AND APPEARANCE

HYDROCORTISONE 
hydrocortisone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49314-5801
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 mL

Inactive Ingredients
Ingredient Name	Strength
alcohol (UNII: 3K9958V90M)
methylparaben (UNII: A2I8C7HI9T)
mineral oil (UNII: T5L8T28FGP)
paraffin (UNII: I9O0E3H2ZE)
petrolatum (UNII: 4T6H12BN9U)
propylparaben (UNII: Z8IX2SC1OH)
water (UNII: 059QF0KO0R)
cetostearyl alcohol (UNII: 2DMT128M1S)
polysorbate 60 (UNII: CAL22UVI4M)
PEG-150 distearate (UNII: 6F36Q0I0AC)
steareth-20 (UNII: L0Q8IK9E08)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49314-5801-0	0.8 mL in 1 PACKET

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part348	07/28/2010

Labeler - UniShield (790677053)

Registrant - Safetec of America, Inc. (874965262)

Establishment
Name	Address	ID/FEI	Business Operations
Safetec of America, Inc.		874965262	MANUFACTURE