Chapstick Medicated
FDA Label NDC 0573-0720

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Haleon Us Holdings Llc for the product Chapstick Medicated (NDC 0573-0720). 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 other, otc - purpose, uses, warnings, otc - when using, stop use and ask a doctor if, otc - keep out of reach of children, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

Otc - Purpose

Active ingredientsPurposes
Camphor 1%External analgesic
Menthol 0.6%External analgesic
Petrolatum 41%Skin protectant
Phenol 0.5%External analgesic

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

Warnings

For external use only

Otc - When Using

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 up and 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.

Directions

  • adults and children 2 years of age and older: apply to lips not more than 3 to 4 times daily
  • children under 2 years of age: ask a doctor

Other Information

  • store at 20-25°C (68-77°F)

Inactive Ingredients

arachidyl propionate, carnauba wax, cetyl alcohol, cocoa butter, fragrance, isopropyl lanolate, isopropyl myristate, lanolin, light mineral oil, octyldodecanol, oleyl alcohol, paraffin, phenyl trimethicone, white wax

Questions Or Comments?

call weekdays from 9 AM to 5 PM at 1-877-227-3421

Principal Display Panel - 4 G Cylinder Blister Pack

BRAND LIP CARE
ChapStick®

EXTERNAL ANALGESIC | SKIN PROTECTANT

CLASSIC
MEDICATED

SOOTHES, COOLS & PROTECTS TO
RELIEVE SEVERELY DRY, CHAPPED LIPS

NET WT 0.15 OZ (4 g)

Principal Display Panel (4 g Cylinder Blister Pack)

Principal Display Panel (4 g Cylinder Blister Pack)

Principal Display Panel - 4 G Cylinder Label

ChapStick®

EXTERNAL ANALGESIC | SKIN PROTECTANT

CLASSIC | MEDICATED

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