Drug Labeling and Warnings

Drug Details

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BLT 1- benzocaine 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

Benzocaine 20%

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

KEEP OUT OF REACH OF CHILDREN

PACKAGE LABELING

BLT 1

BLT 1 
benzocaine ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 70372-727
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE20 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
PEG-100 STEARATE (UNII: YD01N1999R)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
WATER (UNII: 059QF0KO0R)  
CETEARYL OLIVATE (UNII: 58B69Q84JO)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
PEG-8 STEARATE (UNII: 2P9L47VI5E)  
PETROLATUM (UNII: 4T6H12BN9U)  
SORBITAN OLIVATE (UNII: MDL271E3GR)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 70372-727-015 g in 1 POUCH; Type 0: Not a Combination Product10/15/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34810/15/2016
Labeler - CENTURA PHARMACEUTICALS INC (084921637)
Registrant - CENTURA PHARMACEUTICALS INC (084921637)

Revised: 10/2016
 
CENTURA PHARMACEUTICALS INC


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