OLP HYDROCORTISONE 1%- hydrocortisone 1% cream

OLP Hydrocortisone 1% by

Drug Labeling and Warnings

OLP Hydrocortisone 1% by is a Otc medication manufactured, distributed, or labeled by OHIO LAB PHARMA. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Hydrocortisone, USP 1%

PURPOSE

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 ...

WARNINGS

For external use only

DO NOT USE

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

WHEN USING THIS PRODUCT

avoid contact with the eyes do not begin the use of any other hydrocortisone product unless directed by a doctor

for external anal itching: do not use more than directed unless directed by a doctor

do not put this product into the rectum by using fingers or any mechanical device or applicator

STOP USE AND ASK YOUR DOCTOR IF

symptoms last for more than 7 days the condition gets worse symptoms clear up and occur again in a few days rectal bleeding occurs, consult doctor promptly

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.

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
For external anal 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
Children under 12 years of age: consult a doctor

OTHER INFORMATION

Store at room temperature 59°-86°F (15°-30°C). Protect from freezing.
Before using any medication, read all label directions. Keep carton, it contains important information.

INACTIVE INGREDIENTS

cetostearyl alcohol, sodium cetostearyl sulfate, stearic acid, trolamine, decyl oleate, propylene glycol, water, methyl paraben, propyl paraben, EDTA, vitamin E

QUESTIONS

ghassan@ohiolabpharma.com

PACKAGE LABEL

EXTRA STRENGHT

INGREDIENTS AND APPEARANCE

OLP HYDROCORTISONE 1% 
hydrocortisone 1% cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70648-002
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 g

Inactive Ingredients
Ingredient Name	Strength
TROLAMINE (UNII: 9O3K93S3TK)
CETEARETH-12 (UNII: 7V4MR24V5P)
SODIUM CETOSTEARYL SULFATE (UNII: 7ZBS06BH4B)
WATER (UNII: 059QF0KO0R)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
METHYLPARABEN (UNII: A2I8C7HI9T)
ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)
EDETATE DISODIUM (UNII: 7FLD91C86K)
OCTYLDODECANOL (UNII: 461N1O614Y)
STEARIC ACID (UNII: 4ELV7Z65AP)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70648-002-01	1 in 1 CARTON	02/01/2017
1		20 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	02/01/2017

Labeler - OHIO LAB PHARMA (080215854)

Registrant - OHIO LAB PHARMA (080215854)

Establishment
Name	Address	ID/FEI	Business Operations
OHIO LAB PHARMA		080215854	manufacture(70648-002)