Label: PURESKIN TINEA TREATMENT cream
- NDC Code(s): 83565-005-01
- Packager: Stellans Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated October 17, 2023
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- Official Label (Printer Friendly)
- Active Ingredient
- Purpose
- Use
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Warnings
For external use only.
Do not use it on children under two years of age unless directed by a physician.
Avoid contact with the eyes.Keep out of reach of children.
If swallowed, get medical help or contact a poison control center right away.Stop using and consult a physician if
Irritation occurs.
No improvement over 4 weeks. - Do not use
- When Using
- Stop Use
- Ask Doctor
- Keep Out Of Reach Of Children
- Directions
- Other information
- Inactive ingredients
- Questions
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
PURESKIN TINEA TREATMENT
pureskin tinea treatment creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:83565-005 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength THUJA OCCIDENTALIS LEAF (UNII: 0T0DQN8786) (THUJA OCCIDENTALIS LEAF - UNII:0T0DQN8786) THUJA OCCIDENTALIS LEAF 6 g in 100 mL Inactive Ingredients Ingredient Name Strength MURRAYA PANICULATA LEAFY TWIG (UNII: VO9X9681W9) MENTHA CANADENSIS WHOLE (UNII: J1BO4MHT2L) DICTAMNUS DASYCARPUS ROOT (UNII: 6153LEN214) ALOE VERA LEAF (UNII: ZY81Z83H0X) GLYCERIN (UNII: PDC6A3C0OX) SOPHORA FLAVESCENS ROOT (UNII: IYR6K8KQ5K) RHINACANTHUS NASUTUS LEAF (UNII: 97OQD55S9I) EUPHORBIA HIRTA LEAF (UNII: 243K8QF0MS) MENTHOL (UNII: L7T10EIP3A) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) COCONUT OIL (UNII: Q9L0O73W7L) VIOLA ADUNCA WHOLE (UNII: 26Z8E4RZ3Q) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:83565-005-01 60 mL in 1 TUBE; Type 0: Not a Combination Product 10/04/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M005 10/04/2023 Labeler - Stellans Inc. (111157321) Establishment Name Address ID/FEI Business Operations Stellans Inc. 111157321 label(83565-005) , manufacture(83565-005)