CVS CLOTRIMAZOLE MAXIMUM STRENGTH- clotrimazole solution

CVS Clotrimazole by

Drug Labeling and Warnings

CVS Clotrimazole by is a Otc medication manufactured, distributed, or labeled by CVS Pharmacy, Natureplex LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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Drug Facts

Active ingredient

Clotrimazole 1%

Purpose

Antifungal

Use

• for the effective treatment of most athlete's foot (tinea pedis) and ringworm (tinea corporis)

Warnings

For external use only

Do not use

• for diaper rash
• on children under 2 years of age unless directed by a doctor

When using this product

• avoid contact with eyes

Stop use immediately and ask a doctor if

• irritation occurs
• there is no improvement within 4 weeks

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away: 800-222-1222.

Directions

• wash affected area and dry thoroughly
• use brush to 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
• if condition persists longer, consult a doctor
• this product is not effective on the scalp or nails

Other information

• store at 15 to 30°C (59 to 86°F)
• do not use if seal on bottle is punctured or missing

Inactive ingredients

Glycine soja (soybean) oil, melaleuca alternifolia (tea tree) leaf oil, mentha piperita (peppermint) oil

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Distributed by: CVS Pharmacy, Inc.
One CVS Drive, Woonsocket, RI 02895

PRINCIPAL DISPLAY PANEL - 15 mL Bottle Carton

CVS
Health™

Compare to the active
ingredient in Lotrimin®AF*

NDC: 69842-866-01

MAXIMUM STRENGTH
Clotrimazole 1%
ANTIFUNGAL SOLUTION

• Kills most athlete's foot
• Effectively relieves itching,
  burning, cracking & scaling
• Proprietary blend of Tea Tree
  & Peppermint Oil
• Paraben free

Actual Bottle Size
on Side Panel

0.5 FL OZ (15 mL)

INGREDIENTS AND APPEARANCE

CVS CLOTRIMAZOLE  MAXIMUM STRENGTH
clotrimazole solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69842-866
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 mL

Inactive Ingredients
Ingredient Name	Strength
SOYBEAN OIL (UNII: 241ATL177A)
PEPPERMINT OIL (UNII: AV092KU4JH)
TEA TREE OIL (UNII: VIF565UC2G)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69842-866-01	1 in 1 CARTON	02/01/2002
1		15 mL in 1 BOTTLE, WITH APPLICATOR; 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	02/01/2002

Labeler - CVS Pharmacy (062312574)

Establishment
Name	Address	ID/FEI	Business Operations
Natureplex LLC		062808196	MANUFACTURE(69842-866)