BLISTEX COLD AND ALLERGY LIP SOOTHER- dimethicone and pramoxine hydrochloride stick

Blistex by

Drug Labeling and Warnings

Blistex by is a Otc medication manufactured, distributed, or labeled by Blistex Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

• 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

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)

INGREDIENTS AND APPEARANCE

BLISTEX   COLD AND ALLERGY LIP SOOTHER
dimethicone and pramoxine hydrochloride stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10157-9860
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Dimethicone (UNII: 92RU3N3Y1O) (Dimethicone - UNII:92RU3N3Y1O)	Dimethicone	2 g  in 100 g
Pramoxine Hydrochloride (UNII: 88AYB867L5) (Pramoxine - UNII:068X84E056)	Pramoxine Hydrochloride	1 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
green tea leaf (UNII: W2ZU1RY8B0)
chamomile (UNII: FGL3685T2X)
ethyl menthane carboxamide (UNII: 6S7S02945H)
glycerin (UNII: PDC6A3C0OX)
glyceryl monostearate (UNII: 230OU9XXE4)
sunflower oil (UNII: 3W1JG795YI)
honey (UNII: Y9H1V576FH)
lanolin (UNII: 7EV65EAW6H)
microcrystalline wax (UNII: XOF597Q3KY)
myristyl myristate (UNII: 4042ZC00DY)
paraffin (UNII: I9O0E3H2ZE)
phenoxyethanol (UNII: HIE492ZZ3T)
water (UNII: 059QF0KO0R)
european elderberry (UNII: BQY1UBX046)
sodium ascorbyl phosphate (UNII: 836SJG51DR)
hyaluronate sodium (UNII: YSE9PPT4TH)
saccharin sodium (UNII: SB8ZUX40TY)
tridecyl neopentanoate (UNII: 3Z8H1DA7J5)
tangerine (UNII: KH3E3096OO)
ceresin (UNII: Q1LS2UJO3A)
trolamine (UNII: 9O3K93S3TK)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10157-9860-1	1 in 1 CARTON
1		4.25 g in 1 CYLINDER

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part347	07/01/2011

Labeler - Blistex Inc (005126354)

Establishment
Name	Address	ID/FEI	Business Operations
Blistex Inc		005126354	MANUFACTURE