Drug Facts

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)

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

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

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

Labeler - Blistex Inc (005126354)

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

Blistex® COLD & ALLERGY LIP SOOTHER™