ClotrimazOil Antifungal Solution

ClotrimazOil Antifungal Solution

Drug Labeling and Warnings

Drug Details

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AKIN ANTI-FUNGAL- clotrimazole solution 
Southern Sales & Service, Inc.

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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ClotrimazOil Antifungal Solution

Active Ingredient

Clotrimazole 1%

Purpose

Antifungal

Uses:

For the effective treatment of most:

  • athlete’s foot (tinea pedis)
  • ringworm (tinea corporis)

Warnings:

For external use only

When Using This Product

avoid contact with eyes

Stop Use If:

  • irritation occurs
  • there is no improvement within 4 weeks.

KEEP OUT OF REACH OF CHILDREN.

If swallowed, get medical help or contact a Poison Control Center immediately.

Inactive Ingredients:

Glycine Soja (Soybean) Oil, Melaleuca Alternifolia (tea tree) leaf oil, Mentha Piperita.

Directions:

Read all package directions and warnings before using.

  • Wash affected area and dry thoroughly.
  • Apply a thin layer of the product over the affected area twice daily (morning and night) or as directed by a doctor.
  • For athlete’s foot: pay special attention to spaces between 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.
  • Supervise children in the use of this product.

Questions? Comments?

Call 1-800-213-9370

Antifungal Solution  CLOTRIMAZOLE 1%

.5 Fl. oz (15 ml)

Akin Antifungal Solution .5oz/15ml

Label Image
AKIN ANTI-FUNGAL 
clotrimazole solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 69822-254
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CLOTRIMAZOLE (UNII: G07GZ97H65) (CLOTRIMAZOLE - UNII:G07GZ97H65) CLOTRIMAZOLE10 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
GLYCINE (UNII: TE7660XO1C)  
MELALEUCA ALTERNIFOLIA LEAF (UNII: G43C57162K)  
MENTHA PIPERITA (UNII: 79M2M2UDA9)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 69822-254-051 in 1 CARTON01/01/2017
115 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C01/01/2017
Labeler - Southern Sales & Service, Inc. (013114906)
Establishment
NameAddressID/FEIBusiness Operations
Southern Sales & Service, Inc.013114906LABEL(69822-254)
Establishment
NameAddressID/FEIBusiness Operations
GADAL Laboratories, Inc841305639MANUFACTURE(69822-254)

Revised: 1/2017
 
Southern Sales & Service, Inc.


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