Label: SIMPLY VITAL ANTIFUNGAL CREAM- clotrimazole cream
- NDC Code(s): 82460-344-00
- Packager: ALPHA PLANTS INC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated November 11, 2023
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- Official Label (Printer Friendly)
- Drug Facts
- Active ingredient
- Uses:
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Warnings:
For external use only.
When using this product
- avoid contact with the eyes
- irritation occurs.
- condition persists.
- there is no improvement of athlete's foot or ringworm within 4 weeks or jock itch within 2 weeks.
Discontinue use and ask a doctor if
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Directions:
- 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; weat well-fitting, ventilated 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.
- if condition persists longer, consult a doctor.
- this product is not effective on the scalp or nails.
- Other information:
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Inactive ingredients:
Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Cetearyl Alcohol, Cetyl Stearate, Ethylhexyl Palmitate, Ethylhexylglycerin, Glycerin, Hamamelis Virginiana (Witch Hazel), Melaleuca Alternifolia (Tea Tree) Oil, Phenoxyethanol, Polysorbate-20, Propylene Glycol, Sorbitan Stearate, Thymus Vulgaris (Thyme) Extract, Tocopheryl Acetate (Vitamin E), Triethanolamine.
- Questions?
- Package Labeling:
-
INGREDIENTS AND APPEARANCE
SIMPLY VITAL ANTIFUNGAL CREAM
clotrimazole creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:82460-344 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 ALOE VERA LEAF (UNII: ZY81Z83H0X) WATER (UNII: 059QF0KO0R) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) CETYL STEARATE (UNII: 06RI5UQA7L) ETHYLHEXYL PALMITATE (UNII: 2865993309) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) GLYCERIN (UNII: PDC6A3C0OX) HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK (UNII: T7S323PKJS) TEA TREE OIL (UNII: VIF565UC2G) PHENOXYETHANOL (UNII: HIE492ZZ3T) POLYSORBATE 20 (UNII: 7T1F30V5YH) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X) THYME (UNII: CW657OBU4N) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) TROLAMINE (UNII: 9O3K93S3TK) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:82460-344-00 60 mL in 1 JAR; Type 0: Not a Combination Product 07/25/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M005 07/25/2022 Labeler - ALPHA PLANTS INC (118246522)
