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Drug Facts
Blistex
FDA Label NDC 10157-9860
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 10157-9860). 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, when using this product, stop use and ask a doctor if, otc - keep out of reach of children, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
| Active ingredients | Purpose |
| Dimethicone 2.0%(w/w) | Skin protectant |
| Pramoxine HCL 1.0%(w/w) | External analgesic |
Uses
- for the temporary relief of pain and itching associated with minor lip irritations
- temporarily protects and helps relieve chapped or cracked lips
Warnings
For external use only
When Using This Product
- Do not get into eyes
Stop Use And Ask A Doctor If
- condition worsens, or if symptoms persist for 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 liberally to affected area not more than 3 to 4 times daily. Children under 2 years of age: consult a doctor.
Inactive Ingredients
C20-40 pareth-3, camellia sinensis leaf extract, castor oil bis-hydroxypropyl dimethicone esters, chamomilla recutita (matricaria) flower extract, ethyl menthane carboxamide, flavor, glycerin, glyceryl stearate, helianthus annuus (sunflower) seed oil, honey, lanolin, lecithin, microcrystalline wax, myristyl myristate, ozokerite, paraffin, phenoxyethanol, polybutene, purified water, sambucus nigra fruit extract, sodium ascorbyl phosphate, sodium hyaluronate, sodium saccharin, tocopheryl acetate, tridecyl neopentanoate, triethanolamine, triisononanoin
Principal Display Panel 4.25G Carton
NDC 10157-9860-1
Blistex®
New!
EXTERNAL ANALGESIC/
LIP PROTECTANT
COLD &
ALLERGY
LIP SOOTHER™
Relieves Lip Discomfort & Dryness
Due To Illness Or Medication
Infused With Vitamins C&E, Green Tea,
Elderberry, Chamomile And Honey
Applies Gently To Sore Lips
NET WT. .15 oz (4.25g)
Principal Display Panel 4.25g Carton (Blistex 01)
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