ANTI-ITCH FEMININE CARE- hydrocortisone 0.5% cream

ANTI-ITCH FEMININE CARE by

Drug Labeling and Warnings

ANTI-ITCH FEMININE CARE 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 0.5%

PURPOSE

Anti-itch

USES

For temporary external feminine itching

WARNINGS

For External Use Only

Avoid Contact with eyes

DIRETIONS

Adults and children 12 years and older Apply to external vaginal area not more than 3 to 4 times a day
Children under 12 years Consult a doctor

DO NOT USE IF

you have a vaginal discharge. Consult a physician.

KEEP OUT OF REACH OF CHILDREN

If swallowed, get medical help or contact a Poison Control Center right away.

OTHER INFORMATION

• store at 20°-25°C (68°-77°F)

INACTIVE INGREDIENT

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

QUESTIONS

www.ohiolabpharma.us

PACKAGE LABEL

NET WT 1OZ (20G)

HYDROCORTISONE0.5%

INGREDIENTS AND APPEARANCE

ANTI-ITCH FEMININE CARE 
hydrocortisone 0.5% cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70648-103
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ)	HYDROCORTISONE	5 mg  in 1 g

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70648-103-01	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(70648-103)