Blistex Medicated Lip Balm Variety Pack (blistex Medicated Berry Lip Balm, Blistex Medicated Lip Balm, Blistex Medicated Lip) Kit
FDA Label NDC 10157-9910

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 Medicated Lip Balm Variety Pack (blistex Medicated Berry Lip Balm, Blistex Medicated Lip Balm, Blistex Medicated Lip) (NDC 10157-9910). 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, skin cancer/skin aging alert, 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.

Other

MEDICATED BERRY BALM

Drug Facts

For external use only

MEDICATED LIP BALM

Drug Facts

For external use only

MEDICATED LIP OINTMENT

Drug Facts

Otc - Purpose

Active ingredientsPurpose
Dimethicone 2.0% (w/w)Lip protectant
Octinoxate 6.6% (w/w)Sunscreen
Octisalate 4.4% (w/w)Sunscreen
Active ingredientsPurpose
Dimethicone 2.0 % (w/w)Lip protectant
Octinoxate 6.6 % (w/w)Sunscreen
Octisalate 4.4 % (w/w)Sunscreen
Active ingredientsPurpose
Camphor 0.5% (w/w)External analgesic
Dimethicone 1.1% (w/w)Lip protectant
Menthol 0.625% (w/w)External analgesic
Phenol 0.5% (w/w)External analgesic

Uses

  • temporarily protects and helps relieve chapped or cracked lips
  • helps prevent sunburn
    • temporarily protects and helps relieve chapped or cracked lips
    • helps prevent sunburn
      • 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

Skin Cancer/Skin Aging Alert

Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging.

Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging.

Otc - Do Not Use

Do not use on damaged or broken skin

Do not use on damaged or broken skin

Otc - When Using

When using this product keep out of eyes. Rinse with water to remove.

When using this product keep out of eyes. Rinse with water to remove.

Otc - Stop Use

Stop use and ask a doctor if rash occurs

Stop use and ask a doctor if rash occurs

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.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • apply liberally 15 minutes before sun exposure
  • reapply at least every 2 hours
  • use a water resistant sunscreen if swimming or sweating
  • children under 6 months of age: Ask a doctor
    • apply liberally 15 minutes before sun exposure
    • reapply at least every 2 hours
    • use a water resistant sunscreen if swimming or sweating
    • children under 6 months of age: Ask a doctor
      • 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

Other Information

  • protect the product in this container from excessive heat and direct sun
    • protect the product in this container from excessive heat and direct sun

Inactive Ingredients

beeswax, camphor, cetyl alcohol, cetyl palmitate, euphorbia cerifera (candelilla) wax, flavor, isopropyl myristate, lanolin, lanolin oil, menthol, mineral oil, ozokerite, paraffin, petrolatum, phenoxyethanol, polybutene, red 6 lake, theobroma cacao (cocoa) seed butter, titanium dioxide

beeswax, camphor, cetyl alcohol, cetyl palmitate, euphorbia cerifera (candelilla) wax, flavor, isopropyl myristate, lanolin, lanolin oil, menthol, methyl salicylate, mineral oil, ozokerite, paraffin, petrolatum, phenoxyethanol, polybutene, red 6 lake, theobroma cacao (cocoa) seed butter, titanium dioxide

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

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

Principal Display Panel - Kit Carton

Blistex® MEDICATED VARIETY PACK

Helps heal, soothe
& protect

There's No Bliss Like Blistex®

Principal Display Panel (Kit Carton)

Principal Display Panel (Kit Carton)

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