Lip Medex Lip Balm Stick
FDA Label NDC 10157-1194

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 Lip Medex Lip Balm (NDC 10157-1194). 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 - do not use, otc - when using, otc - stop use, 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 42% (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

Otc - Do Not Use

Do not use on:

  • deep or puncture wounds
  • animal bites
  • serious burns

Otc - When Using

When using this product:

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

Otc - Stop Use

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, cetyl alcohol, eucalyptus globulus leaf oil, eugenia caryophyllus (clove) flower oil, fragrance, isopropyl myristate, lanolin, menthoxypropanediol, menthyl lactate, methyl salicylate, microcrystalline wax, octyldodecanol, ozokerite, phenyl trimethicone, polyethylene, ricinus communis (castor) seed oil, saccharin, sorbitan isostearate, theobroma cacao (cocoa) seed butter, trimethylolpropane tricaprylate/tricaprate

Principal Display Panel - 4.25 G Stick Carton

Blistex®
NEW

DERMATOLOGIST RECOMMENDED

LIP MEDEX®

LIP PROTECTANT/EXTERNAL ANALGESIC

Delivers Instant Moisturization & Helps
Prevent Future Dryness

Quickly Cools & Comforts Dry, Sore Lips

3 Pack

3 Sticks Net Wt. 0.15 oz. (4.25 g) Ea.

Principal Display Panel (4.25 g Stick Carton)

Principal Display Panel (4.25 g Stick Carton)

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