CLOTRIMAZOLE- clotrimazole solution 
ACINO PRODUCTS LIMITED LIABILITY COMPANY

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.

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ACINO PRODUCTS - CLOTRIMAZOLE (TOPICAL SOLUTION) USP 1%

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
• 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.

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

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

call 1-877-227-2594

ACINO_clotrimazole carton 10mLCP

CLOTRIMAZOLE 
clotrimazole solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68784-301
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CLOTRIMAZOLE (UNII: G07GZ97H65) (CLOTRIMAZOLE - UNII:G07GZ97H65) CLOTRIMAZOLE1 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68784-301-101 in 1 BOX07/29/2019
1NDC:68784-301-0110 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C07/29/2019
Labeler - ACINO PRODUCTS LIMITED LIABILITY COMPANY (019385518)
Establishment
NameAddressID/FEIBusiness Operations
ACINO PRODUCTS LIMITED LIABILITY COMPANY019385518manufacture(68784-301)

Revised: 5/2021
Document Id: c2b0938f-056b-25c5-e053-2995a90a6e1b
Set id: d70dbfaa-104e-48ae-97e5-57bf7c8ef144
Version: 3
Effective Time: 20210519
 
ACINO PRODUCTS LIMITED LIABILITY COMPANY