Label: APTRIMAZOLE 1.0% ANTIFUNGAL CREAM- clotrimazole cream
- 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.
Updated April 27, 2013
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- ACTIVE INGREDIENT
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
Do not use:
Do not use on children under 2 years of age unless directed by a doctor.
Avoid contact with eyes.
For athletes foot and ringworm - if irritation occurs, or if there is no improvement within 4 weeks, discontinue use and consult a doctor.
For jock itch - if irritation occurs, or if there is no improvement within two weeks, discontinue use and consult a doctor.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Clean the affected area and dry thoroughly. Apply a layer of cream 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 toes: wear well fitting, ventilated shoes, and change shoes and socks at least once daily.
Foe athlete's foot and ringworm, use daily for 4 weeks.
For jock itch, use daily for 2 weeks.
If conditions persist longer, consult a doctor.
This product is not effective on scalp or nails.
- INACTIVE INGREDIENT
- DISPLAY PANEL
INGREDIENTS AND APPEARANCE
APTRIMAZOLE 1.0% ANTIFUNGAL CREAM
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:46084-081 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CLOTRIMAZOLE (UNII: G07GZ97H65) (CLOTRIMAZOLE - UNII:G07GZ97H65) CLOTRIMAZOLE 1 g in 100 g Inactive Ingredients Ingredient Name Strength PETROLATUM (UNII: 4T6H12BN9U) LIGHT MINERAL OIL (UNII: N6K5787QVP) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) EDETIC ACID (UNII: 9G34HU7RV0) CHLOROCRESOL (UNII: 36W53O7109) SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F) POLYSORBATE 60 (UNII: CAL22UVI4M) CETETH-20 (UNII: I835H2IHHX) Product Characteristics Color white (offwhite) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:46084-081-31 15 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333C 04/27/2013 Labeler - A P J Laboratories Limited (677378339) Registrant - A P J Laboratories Limited (677378339) Establishment Name Address ID/FEI Business Operations A P J Laboratories Limited 677378339 manufacture(46084-081)