Label: VOTRIZA-AL- clotrimazole 1% lotion
- NDC Code(s): 83035-1061-3
- Packager: Singular Dreamer, Ltd dba True Marker
- 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.
Drug Label Information
Updated May 24, 2023
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- Active ingredients
- Purpose
- Uses
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Warnings
- For external use only.
- Do not use on children under 2 years of age unless directed by a doctor
- When using this product Avoid contact with eyes.
- Stop use and ask a doctor if irritation occurs or if there is no improvement within 4 weeks,discontinue use and consult a doctor (within 2 weeks for jock itch).
- Keep out of the reach of children. If swallowed, get medical help or contact a Poison Control Center right away. If pregnant or breast-feeding, ask a health professional before use
- KEEP OUT OF REACH OF CHILDREN
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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; 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.
- 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 Esters, Ethylhexyl Palmitate, Ethylhexylglycerin, Hamamelis Virginiana (Witch Hazel), Melaleuca Alternifolia (Tea Tree) Oil, Phenoxyethanol, Polysorbate-20, Sorbitan Stearate, Thymus Vulgaris (Thyme) Extract, Tocopheryl Acetate (Vitamin E), Triethanolamine.
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INGREDIENTS AND APPEARANCE
VOTRIZA-AL
clotrimazole 1% lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:83035-1061 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 mL Inactive Ingredients Ingredient Name Strength CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L) ALOE VERA LEAF (UNII: ZY81Z83H0X) WATER (UNII: 059QF0KO0R) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) CETYL ESTERS WAX (UNII: D072FFP9GU) ETHYLHEXYL PALMITATE (UNII: 2865993309) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) WITCH HAZEL (UNII: 101I4J0U34) TEA TREE OIL (UNII: VIF565UC2G) PHENOXYETHANOL (UNII: HIE492ZZ3T) POLYSORBATE 20 (UNII: 7T1F30V5YH) 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:83035-1061-3 1 in 1 CARTON 05/20/2023 1 30 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333C 05/20/2023 Labeler - Singular Dreamer, Ltd dba True Marker (129504103) Registrant - Singular Dreamer, Ltd dba True Marker (129504103)