Label: KINESYS- zinc oxide cream
- NDC Code(s): 61481-0036-2
- Packager: Wilc Healthcare Inc
- Category: HUMAN OTC DRUG LABEL
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 September 26, 2018
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- Active Ingredient
- Purpose
- Uses
- Warnings
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Directions
- Apply generously and spread evenly to all exposed skin 20 minutes before sun exposure
Reapply:
- after 80 minutes of swimming or sweating
- immediately after towel drying
- at least every 2 hours
Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including:
- limit time in the sun, especially from 10 a.m. – 2 p.m.
- wear long-sleeve shirts, pants, hats, and sunglasses
children under 6 months: Ask a doctor
- Inactive Ingredients
- Other Information
- Questions or Comments?
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
KINESYS
zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:61481-0036 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 25 g in 100 g Inactive Ingredients Ingredient Name Strength ALOE VERA LEAF (UNII: ZY81Z83H0X) LEVOMENOL (UNII: 24WE03BX2T) COCONUT OIL (UNII: Q9L0O73W7L) PEPPERMINT OIL (UNII: AV092KU4JH) ISOSTEARIC ACID (UNII: X33R8U0062) ROSEMARY OIL (UNII: 8LGU7VM393) SUNFLOWER OIL (UNII: 3W1JG795YI) TOCOPHEROL (UNII: R0ZB2556P8) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:61481-0036-2 60 g in 1 JAR; Type 0: Not a Combination Product 09/26/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part348 09/26/2018 Labeler - Wilc Healthcare Inc (203499140) Registrant - Wilc Healthcare Inc (203499140) Establishment Name Address ID/FEI Business Operations Cosmaceutical Research Laboratory Inc 256797309 manufacture(61481-0036)