Clotrimazole by Pedifix / Pure Source CLOTRIMAZOLE liquid

Clotrimazole by

Drug Labeling and Warnings

Clotrimazole by is a Otc medication manufactured, distributed, or labeled by Pedifix, Pure Source. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

Clotrimazole 1%

Inactive ingredients

Aqua, BHT, safflower oil, emu oil, eucalyptus globlus oil, soybean oil, lavender oil, tea tree oil, peppermint oil, olive fruit oil, sweet almond oil, rose hip oil, jojoba oil, vitamin E, urea

Purpose

Anti-fungal

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children

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

Apply to skin around affected areas. While not allfinger and toe fungal infections are curabel with OTC topical medications. If you see improvement whithin 4 weeks of use, you may continue to use until satisfactory results are obtained.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CLOTRIMAZOLE 
clotrimazole liquid

Product 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)