FDA Label for Medicated Body Powder
View Indications, Usage & Precautions
Medicated Body Powder Product Label
The following document was submitted to the FDA by the labeler of this product Meijer Distribution, Inc. 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.
Otc - Active Ingredient
Active ingredientsMenthol 0.15%Zinc oxide 1.0%
Otc - Purpose
PurposeExternal analgesicSkin protectant
Indications & Usage
Uses for the temporary relief of pain and itching due to: • minor cuts • sunburn • insect bites • poison ivy• poison oak • poison sumac • scrapes • minor burns • monor skin irritationsdries the oozing and weeping of:• poison ivy • poison oak • poison sumac
Warnings
WarningsFor external use only
Otc - When Using
When using this product avoid contact with the eyes
Otc - Stop Use
Stop use and ask a doctor if condition worsens, or if symptoms persist form more than 7 days or clear up and occur again withing a few days
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control center right away.
Dosage & Administration
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 Ingredient
Inactive ingredients talc, acacia, eucalyptol, methyl salicylate, salicylic acid, thymol, zinc stearate
Other
This product is not manufactured or distributed by Chattem, Inc.,owner of the registered trademark Gold Bond.This product is sold by weight, not by volume.Some settling may occur during the handling and shipping.
Adverse Reactions
DIST. BY MEIJER DISTRIBUTION, INC.2929 WALKER AVE NWGRAND RAPIDS, MI 49544www.meijer.com
Package Label.Principal Display Panel
MeijerMEDICATEDBODY POWDERSKIN PROTECTANTEXTERNAL ANALGESICCOOLING • ABSORBINGITCH RELIEVINGCOMPARE TO THE ACTIVE INGREDIENTS OF GOLD BONDMEDICATED BODY POWDERNET WT 10 OZ (283 g)
* Please review the disclaimer below.