CLOTRIMAZOLE- drs. clotrimazole cream

Clotrimazole by

Drug Labeling and Warnings

Clotrimazole by is a Otc medication manufactured, distributed, or labeled by OL PHARMA TECH,LLC, OL PHARMA TECH,LLC (Drs, pharmacy). 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:

• irritation 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, mineral oil , ceteareth-12, propylene glycol, methyl parabeen, propyl paraben, EDTA disodium, vitamin E, water

For Questions:

www.drspharmacyusa.com

PRINCIPAL DISPLAY PANEL

original strenghth

Antifungal cream

INGREDIENTS AND APPEARANCE

CLOTRIMAZOLE 
drs. clotrimazole cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80489-002
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
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
EDETATE DISODIUM (UNII: 7FLD91C86K)
CETEARETH-12 (UNII: 7V4MR24V5P)
METHYLPARABEN (UNII: A2I8C7HI9T)
STEARIC ACID (UNII: 4ELV7Z65AP)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
MINERAL OIL (UNII: T5L8T28FGP)
SODIUM CETOSTEARYL SULFATE (UNII: 7ZBS06BH4B)
TROLAMINE (UNII: 9O3K93S3TK)
WATER (UNII: 059QF0KO0R)
PROPYLPARABEN (UNII: Z8IX2SC1OH)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80489-002-01	1 in 1 CARTON	01/01/2021
1		28.3 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	01/01/2021

Labeler - OL PHARMA TECH,LLC (021170377)

Registrant - OL PHARMA TECH,LLC (021170377)

Establishment
Name	Address	ID/FEI	Business Operations
OL PHARMA TECH,LLC (Drs, pharmacy)		021170377	manufacture(80489-002)