BLT 3- tetracaine ointment

BLT 3 by

Drug Labeling and Warnings

BLT 3 by is a Otc medication manufactured, distributed, or labeled by CENTURA PHARMACEUTICALS INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Tetracaine 2%

PURPOSE

Topical Anesthetic

USES

For the temporary relief of pain and itching.

WARNINGS

For external use only.
Avoid contact with eyes or mucus membranes.
Do not apply to open or damaged skin.
If condition worsens or symptoms persist for
more than seven days, discontinue use and
consult physician.
If pregnant or breast feeding,contact physician
prior to use.
Keep out of reach of children. If swallowed,
contact Poison Control Center.
Do not use if allergic to any ingredient in ointment.
Do not use in large quantities, particularly over
raw surfaces or blistered areas.

DIRECTIONS

Adults and children two-years of age or
older: Apply to affected area not more than three to
four times daily. Children under two-years of age:
consult a physician.

OTHER INFORMATION

Store below 77° F (25° C). Avoid
direct sunlight.

INACTIVE INGREDIENTS

Acrylates, C10-30 Alkyl Acrylate
Crosspolymer, Aqua (Deionized Water), Beeswax, Benzyl
Alcohol, Cetyl Alcohol, Dehydroacetic Acid, Glycerin,
Helianthus Annuus (Sunflower) Oil, Polysorbate 20,
Sodium Hydroxide, Stearic Acid.

KEEP OUT OF REACH OF CHILDREN

PACKAGE LABELING

INGREDIENTS AND APPEARANCE

BLT 3 
tetracaine ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70372-729
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TETRACAINE (UNII: 0619F35CGV) (TETRACAINE - UNII:0619F35CGV)	TETRACAINE	2 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
DEHYDROACETIC ACID (UNII: 2KAG279R6R)
GLYCERIN (UNII: PDC6A3C0OX)
SUNFLOWER OIL (UNII: 3W1JG795YI)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
YELLOW WAX (UNII: 2ZA36H0S2V)
CETYL ALCOHOL (UNII: 936JST6JCN)
STEARIC ACID (UNII: 4ELV7Z65AP)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
WATER (UNII: 059QF0KO0R)
BENZYL ALCOHOL (UNII: LKG8494WBH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70372-729-01	5 g in 1 POUCH; Type 0: Not a Combination Product	10/30/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	10/30/2016

Labeler - CENTURA PHARMACEUTICALS INC (084921637)

Registrant - CENTURA PHARMACEUTICALS INC (084921637)