Blistex Lip Medex Paste
FDA Label NDC 10157-8407

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Blistex Inc. for the product Blistex Lip Medex (NDC 10157-8407). 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, do not use on, when using this product, stop use and ask a doctor if, otc - keep out of reach of children, 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 ingredientsPurpose
Camphor 1.0% (w/w)External analgesic
Menthol 1.0% (w/w)External analgesic
Petrolatum 59.14% (w/w)Lip protectant
Phenol 0.54% (w/w)External analgesic

Uses

  • for the temporary relief of pain and itching associated with minor lip irritation
  • temporarily protects and helps relieve chapped or cracked lips
  • helps protect lips from the drying effects of wind and cold weather

Warnings

For external use only

Do Not Use On

  • deep or puncture wounds
  • animal bites
  • serious burns

When Using This Product

  • do not get into eyes
  • do not apply over large areas of the body or bandage

Stop Use And Ask A Doctor If

  • condition worsens
  • symptoms last 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 affected area not more than 3 to 4 times daily
  • children under 2 years of age: Consult a doctor

Inactive Ingredients

beeswax, benzyl alcohol, diisopropyl adipate, flavors, fragrances, lanolin, menthoxypropanediol, microcrystalline wax, myristyl myristate, ricinus communis (castor) seed oil, saccharin, theobroma cacao (cocoa) seed butter

Principal Display Panel - 7.08 G Jar Blister Pack

NDC 10157-8407-1

Blistex®

LIP PROTECTANT/
EXTERNAL ANALGESIC

LIP MEDEX®

Relieves Sore Lips &
Restores Moisture Balance

Quickly Cools & Comforts

NET WT. .25 oz (7.08g)

Principal Display Panel (7.08 g Jar Blister Pack)

Principal Display Panel (7.08 g Jar Blister Pack)

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