FDA Label for Lip Medex Lip Balm

View Indications, Usage & Precautions

Lip Medex Lip Balm Product Label

The following document was submitted to the FDA by the labeler of this product Blistex Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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.


* Please review the disclaimer below.