Drug Labeling and Warnings

Drug Details

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BLT 3- tetracaine ointment 
CENTURA PHARMACEUTICALS INC

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.

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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

BLT 3

BLT 3 
tetracaine ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 70372-729
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TETRACAINE (UNII: 0619F35CGV) (TETRACAINE - UNII:0619F35CGV) TETRACAINE2 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
CETYL ALCOHOL (UNII: 936JST6JCN)  
DEHYDROACETIC ACID (UNII: 2KAG279R6R)  
GLYCERIN (UNII: PDC6A3C0OX)  
SUNFLOWER OIL (UNII: 3W1JG795YI)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
YELLOW WAX (UNII: 2ZA36H0S2V)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
WATER (UNII: 059QF0KO0R)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 70372-729-015 g in 1 POUCH; Type 0: Not a Combination Product10/30/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34810/30/2016
Labeler - CENTURA PHARMACEUTICALS INC (084921637)
Registrant - CENTURA PHARMACEUTICALS INC (084921637)

Revised: 10/2016
 
CENTURA PHARMACEUTICALS INC


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