Label: MEDICATED BODY POWDER- menthol and zinc oxide powder
- NDC Code(s): 59240-001-01
- Packager: MAGVERZ INC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
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Zinc Oxide 1.0%
Temporarily relieves the pain and itch associated with
- Sunburn Insect Bites
- Scrapes Prickly
- Burns Rashes
- Minor Skin Irritations
Temporarily relieves the pain and itchClose
- Adults and children 2 years and older apply freely up to 3 or 4 times daily.
- Children under 2 years ask a doctor.
- For best results dry skin thoroughly before applying.
For external use only.
When using this product avoid contact with eyes.
Stop use and ask doctor if condition worsens, symptomos do not get better within 7 days.Close
- Keep Out of Reach of Childrens
Keep out of reach of childrens.Close
- Product Label
- INGREDIENTS AND APPEARANCE
MEDICATED BODY POWDER
menthol and zinc oxide powder
Product Information Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:59240-001 Route of Administration TOPICAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL (MENTHOL) MENTHOL 0.15 g in 100 g ZINC OXIDE (ZINC OXIDE) ZINC OXIDE 1 g in 100 g Inactive Ingredients Ingredient Name Strength TALC Salicylic Acid ACACIA EUCALYPTOL METHYL SALICYLATE THYMOL ZINC STEARATE Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:59240-001-01 113 g in 1 CONTAINER Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part347 07/18/2013 Labeler - MAGVERZ INC (078712269) Registrant - MAGVERZ INC (078712269)