Clotrimazole by Akron Pharma Inc / SLV PHARMACEUTICALS LLC CLOTRIMAZOLE solution

Clotrimazole by

Drug Labeling and Warnings

Clotrimazole by is a Otc medication manufactured, distributed, or labeled by Akron Pharma Inc, SLV PHARMACEUTICALS LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Clotrimazole USP, 1%

Purpose

Antifungal

Uses

Cures most

• Athlete's foot (tinea pedis)
• Jock Itch (tinea cruris)
• Ringworm (tinea corporis)

Effectively relieves

• Itching
• Cracking
• Burning

Discomfort which can accompany these conditions

Warnings

For external use only

Ask a doctor before use

on children under 2 years of age

When using this product

avoid contact with eyes

Stop use and ask a doctor if

• irritation occurs
• there is no improvement within 4 weeks (for athlete's foot and ringworm) or 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

• This product is not effective on the scalp or nails For best results, follow directions and continue treatment for length of time indicated. For athlete's foot and ringworm: use daily for 4 weeks. For jock itch: use daily for 2 weeks.
• clean 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; change shoes and socks at least once daily

Other information

• Store at 15° to 30°C (59° to 86°F)

Inactive ingredient

polyethylene glycol 400

Questions?

Please Call 1-877-225-6999

PRINCIPAL DISPLAY PANEL - 10 mL Bottle Carton

NDC: 71399-0500-1

Compare to the active ingredient of Lotrimin®AF*

Clotrimazole Topical Solution USP,1%

Antifungal

• Relieves Itching & Burning
• Greaseless, Nonstaining

For External use only.
Not for Opthalmic use.

Keep this and all medications out of the reach of children.

Akron Pharma

10ml

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INGREDIENTS AND APPEARANCE

CLOTRIMAZOLE 
clotrimazole solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71399-0500
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Clotrimazole (UNII: G07GZ97H65) (Clotrimazole - UNII:G07GZ97H65)	Clotrimazole	1 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
polyethylene glycol 400 (UNII: B697894SGQ)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71399-0500-1	10 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/15/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part333C	05/15/2017

Labeler - Akron Pharma Inc (067878881)

Registrant - Akron Pharma Inc (067878881)

Establishment
Name	Address	ID/FEI	Business Operations
SLV PHARMACEUTICALS LLC		081225162	manufacture(71399-0500)