Label: CLOTRIMAZOLE liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 68927-3491-1 - Packager: Pedifix
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated May 7, 2014
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
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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 doctor if irritation occurs, there is no improvement within 4 weeks (2 weeks for jock itch)
If swallowed, get medical help or contact a poison control center immediately - Active ingredient
- Inactive ingredients
- Purpose
- KEEP OUT OF REACH OF CHILDREN
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Directions
Read all package directions and warnings before using:
Use only as directed
Clean the affected area with soap and warm water and dry throughly
Apply a thin layer over the affected area twice daily (morning and night) or as directed by a doctor
This product is not effective on the scalp or nails
Avoid applying to severly cracked or irritated areas
For athlete's foot pay special attention to spaces between toes, wear well-fitting vetilated 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
Supervise children in the use of this product
Intended foruse by normally healthy adults only
Persons under 18 years of age or thoes with sensitive or allergic skin should use only as directed by a doctor. - Other information
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
CLOTRIMAZOLE
clotrimazole liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68927-3491 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 WATER (UNII: 059QF0KO0R) CARTHAMUS TINCTORIUS FLOWER OIL (UNII: SDQ136WIM5) EMU OIL (UNII: 344821WD61) EUCALYPTUS GLOBULUS WHOLE (UNII: SI1P2XF3M3) SOYBEAN OIL (UNII: 241ATL177A) LAVENDER OIL (UNII: ZBP1YXW0H8) TEA TREE OIL (UNII: VIF565UC2G) PEPPERMINT OIL (UNII: AV092KU4JH) OLEA EUROPAEA FRUIT VOLATILE OIL (UNII: 8E7358CX1J) ALMOND OIL (UNII: 66YXD4DKO9) ROSA CANINA FLOWER OIL (UNII: DUY7M48I1T) JOJOBA OIL (UNII: 724GKU717M) UREA (UNII: 8W8T17847W) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68927-3491-1 15 mL in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333C 05/05/2014 Labeler - Pedifix (122271935) Establishment Name Address ID/FEI Business Operations Pure Source 969241041 manufacture(68927-3491)