Otc - Active Ingredient
Active ingredients Purpose
Allantoin (0.5%) Skin protectant
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Anti-chafe Stick
FDA Label NDC 76347-125
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Mission Product Holdings for the product Anti-chafe Stick (NDC 76347-125). 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, otc - keep out of reach of children, indications & usage, warnings, dosage & administration, inactive ingredient, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Uses: Helps Prevent and temporarily relieve chafed, chapped or cracked skin
Helps protect from the drying effects of wind and cold weather
Temporarily protects minor cuts, scrapes , burns
Otc - Keep Out Of Reach Of Children
Keep out of reach of children
Indications & Usage
Stop use and ask a doctor if
Conditions worsens
symptoms last more than 7 days or clear up and occur again within a few days
Warnings
Warnings: For external use only
When using this product: do not get into eyes
Do not use on: deep puncture wounds, Animal bites , Serious burns
If swallowed,get medical or contact Poison Control Center
Dosage & Administration
Directions: apply as needed
Inactive Ingredient
Inactive ingredients: Glycine soja (soybean) oil, hydrogenated cottonseed oil, dicaprylyl carbonate, beeswax, cyclopentasiloxane, stearyl alcohol, Euphorbia Cerifera (candelilla) wax, ozokerite, talc, silica, dimethicone, butyrospermum parkii (shea butter), tocopheryl acetate, retinyl palmitate, pyridoxine HCL, Sodium ascorbyl phosphate, cholecalciferol, zea mays (corn) oil, phytonidone, aloe barbadensis leaf extract, euterpe oleracea seed oil, punica granatum seed oil, vaccinium macrocarpon (cranberry) seed oil, carthamus tinctorius (safflower) seed oil, lycium barbarum fruit extract.
Package Label.Principal Display Panel
5 hour (TM)
Anti-chafe stick
Pro series
Net. Wt. 1.5 oz (42 G)
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