Otc - Active Ingredient
Active ingredientsMenthol 0.15%Zinc oxide 1.0%
Medicated Body
FDA Label NDC 49348-834
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Mckesson for the product Medicated Body (NDC 49348-834). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, indications & usage, warnings, otc - when using, otc - stop use, otc - keep out of reach of children, dosage & administration, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
PurposeExternal analgesicSkin protectant
Indications & Usage
Uses for temporary relief of pain and itching due to:•minor cuts •sunburn •insect bites•poison ivy •poison oak •poison sumac•scrapes •minor burns •minor 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 for more than 7 days or clear upand occur again within 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
Directionsadults and children 2 years of age and older - apply to affected area not more than 3 to 4 times dailychildren 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., distributor of Gold Bond Medicated Body Powder.This product is sold by weight, not volume. Some settling may occur during handling and shippint
Adverse Reactions
Another Quality ProductDistributed By McKessonOne Post StreetSan Francisco, CA 94104Money Back GuaranteePlease visit us atwww.sunmarkbrand.com
Package Label.Principal Display Panel
SunmarkCompare toGold BondMedicatedBodyPowderSkin ProtectantExternal AnalgesicCoolingAbsorbingItch RelievingNET WT 10 OZ (283 g)
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