FDA Label for Body
View Indications, Usage & Precautions
Body Product Label
The following document was submitted to the FDA by the labeler of this product Major Pharmaceuticals. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Active Ingredient
Menthol 0.15%
Purpose
External analgesic
Uses
for temporary relief of pan and itching due to:
- mnor cuts
- sunburn
- insect bites
- poison ivy
- poison oak
- poison sumac
- scrapes
- minor burns
- minor skin irritations
Warnings
For external use only
When Using This Product
avoid contact with the eyes
Stop Use And Ask A Doctor
If condition worsens, or if symtpoms persist for more than 7 days or clear up and occur again within a few days
Keep Out Of Reach Of Children
If swallowed, get medical help or contact a Poison Control Center right away.
Directions
adults and children 2 years of age and older - apply to affected area not more than 3 to 4 times daily
children under 2 years of age - do not use, consult a doctor
- for best results dry skin thoroughly before applying
Inactive Ingredients
Zea mays (corn) starch, sodium bicarbonate, tricalcium phosphate, zinc oxide, acacia seyal gum, eucalyptol, methyl salicylate, salicylic acid, thymol, zinc stearate
Questions
Call 1-800-616-2471
Disclaimers
This product is not manufactured or distributed by Chattem, distributor of Gold Bond Medicated Body Powder.
This product is sold by weight, not by volume. Some settling may occur during handling and shipping
Adverse Reaction
Distributed By
MAJOR PHARMACEUTICALS
31778 ENTERPRISE DRIVE
LIVONIA, MI 48150 USA
Principal Display Panel
NDC 0904-6348-77
MAJOR
MEDICATED
BODY POWDER
Pain Relieving Powder
WITH ESSENTIAL OILS
Compare to Gold Bond Medicated
Body Powder
Soothes
Absorbs Moisture
Menthol 0.15 % Anti-Itch
NET WT 10 OZ (283 g)
* Please review the disclaimer below.