Blistex Ointment
FDA Label NDC 10157-9951

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 (NDC 10157-9951). 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 0.5% (w/w)External analgesic
Dimethicone 1.1% (w/w)Lip protectant
Menthol 0.6% (w/w)External analgesic
Phenol 0.5% (w/w)External analgesic

Uses

  • for the temporary relief of pain and itching associated with minor lip irritation or cold sores
  • temporarily protects and helps relieve chapped or cracked lips

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

allantoin, ammonium hydroxide, beeswax, calcium disodium EDTA, calcium hydroxide, cetyl alcohol, flavors, glycerin, hydrated silica, lanolin, lauric acid, mineral oil, myristic acid, oleic acid, palmitic acid, paraffin, petrolatum, polyglyceryl-3 diisostearate, potassium hydroxide, purified water, SD alcohol 36, sodium hydroxide, sodium saccharin, stearyl alcohol

Principal Display Panel - 6 G Tube Carton

NDC 10157-9951-2

Blistex®

MEDICATED
LIP OINTMENT

LIP PROTECTANT/
EXTERNAL ANALGESIC

NET WT..21oz(6g)

Helps Heal Severe Dryness And Relieve Cold Sores

Principal Display Panel (6 g Tube Carton)

Principal Display Panel (6 g Tube Carton)

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