Blistex Cold and Allergy Lip Soother

Dosage form: stick
Ingredients: Dimethicone 2g in 100g, Pramoxine Hydrochloride 1g in 100g
Labeler: Blistex Inc
NDC Code: 10157-9860

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Blistex®
COLD & ALLERGY
LIP SOOTHER™

Drug Facts

Active ingredientsPurpose
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

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)

BLISTEX   COLD AND ALLERGY LIP SOOTHER
dimethicone and pramoxine hydrochloride stick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10157-9860
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Dimethicone (Dimethicone) Dimethicone2 g  in 100 g
Pramoxine Hydrochloride (Pramoxine) Pramoxine Hydrochloride1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
green tea leaf 
chamomile 
ethyl menthane carboxamide 
glycerin 
glyceryl monostearate 
sunflower oil 
honey 
lanolin 
microcrystalline wax 
myristyl myristate 
paraffin 
phenoxyethanol 
water 
european elderberry 
sodium ascorbyl phosphate 
hyaluronate sodium 
saccharin sodium 
tridecyl neopentanoate 
tangerine 
ceresin 
trolamine 
Packaging
#Item CodePackage Description
1NDC:10157-9860-11 CYLINDER (CYLINDER) in 1 CARTON
14.25 g in 1 CYLINDER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34707/01/2011
Labeler - Blistex Inc (005126354)
Establishment
NameAddressID/FEIOperations
Blistex Inc005126354MANUFACTURE

Revised: 09/2011
 
Blistex Inc

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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