Otc - Active Ingredient
Active Ingredients:
Camphor
Menthol
White Petrolatum
Chapstick Classic Medicated Stick
FDA Label NDC 83711-809
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Suave Brands Co., Llc for the product Chapstick Classic Medicated (NDC 83711-809). 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, inactive ingredient, indications & usage, otc - keep out of reach of children, otc - purpose, warnings, dosage & administration, 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
Inactive Ingredient
Inactive Ingredients: arachidyl propionate, cetyl alcohol, Copernicia cerifera (carnauba) wax, fragrance, isopropyl lanolate, isopropyl myristate, lanolin, light mineral oil, octyldodecanol, oleyl alcohol, paraffin, phenyl trimethicone, Theobroma cacao (cocoa) seed butter, white wax
Indications & Usage
Uses:
Helps prevent and temporarily protects chafed, chapped, or cracked lips
Temporary relief of pain associated with fever blisters and cold sores
Helps prevent and protect from the drying effects of wind and cold weather
Otc - Keep Out Of Reach Of Children
Warnings
- For external use only
- When using this product avoid contact with the eyes
- Stop use and ask a doctor if
- Condition worsens
- symptoms persist for more than 7 days or clear and ocur again within a few days
- Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Otc - Purpose
Purpose
External analgesic
Skin Protectant
Warnings
Warnings
- For external use only
- When using this product avoid contact with the eyes
- Stop use and ask a doctor if
- Condition worsens
- symptoms persist for more than 7 days or clear and ocur again within a few days
- 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 under 2 years or age and older:
- children under 2 years of age: ask doctor
apply to lips not more than 3 to 4 times daily
* Please review the disclaimer below.
