OLP CLOTRIMAZOLE- clotrimazole cream

OLP CLOTRIMAZOLE by

Drug Labeling and Warnings

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

Drug Details [pdf]

ACTIVE INGREDIENT

Clotrimazole 1%

PURPOSE

Antifungal

USES

• cures most athlete's foot, jock itch and ringworm
• relieves itching, burning, cracking, scaling and discomfort which accompany these conditions

WARNINGS

For external use only

Do not use:

• Do not use on children under 2 years of age unless directed by a doctor.

WHEN USING THIS PRODUCT

avoid contact with the eyes

Stop use and ask your doctor if:

• rritation occurs
• there is no improvement within 4 weeks (for athlete's foot and ringworm) or within 2 weeks (for jock itch)

Keep out of reach of children.

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

Directions

• wash the affected area and dry thoroughly
• apply a thin layer of the product over affected area twice daily (morning and night), or as directed by a

doctor

• supervise children in the use of this product
• for athlete's foot: pay special attention to spaces between the toes; wear well-fitting, ventilated shoes,

and change shoes and socks at least once daily

• for athlete's foot and ringworm, use daily for 4 weeks; for jock itch, use daily for 2 weeks
• if condition lasts longer, contact a doctor
• this product is not effective on the scalp or nails

Other information

• store at controlled room temperature 59°-86°F (15°-30°C).
• before using any medication, read all label directions. Keep carton, it contains important information.

Inactive ingredients

sodium cetostearyl sulfate, cetostearyl alcohol, stearic acid, trolamine, octyldodecanol, ceteareth-12, propylene glycol, methyl parabeen, propyl paraben, EDTA disodium, vitamin E, water

Questions

www.ohiolabpharma.us

PACKAGE LABEL

OLP CLOTRIMAZOLE 1%

INGREDIENTS AND APPEARANCE

OLP CLOTRIMAZOLE 
clotrimazole cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70648-500
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CLOTRIMAZOLE (UNII: G07GZ97H65) (CLOTRIMAZOLE - UNII:G07GZ97H65)	CLOTRIMAZOLE	10 mg  in 1 g

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

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70648-500-01	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 final	part333C	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(70648-500)