Brace Relief by InfaLab,Inc / PhytogenX,Inc.

Brace Relief by

Drug Labeling and Warnings

Brace Relief by is a Otc medication manufactured, distributed, or labeled by InfaLab,Inc, PhytogenX,Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

BRACE RELIEF- benzocaine gel 
InfaLab,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 INGREDIENTS:

Benzocaine 9%

INACTIVE INGREDIENTS:

PEG 8, PEG 75, Glycerine, Tincture of Myrrh, Menthol, Phenol, Clove Oil, Methyl Salicylate, Peppermint Oil, Methyl Paraben, Propyl Paraben.

DIRECTIONS:

Apply to irritated areas as needed See package insert for instructions, warnings & cautions.

CAUTION:

For temporary relief only.

Dist.by Infa-Lab Inc., Rockaway, NJ 07866
1996 INFA-LAB INC., Rockaway, NJ

 

 

 

Principal Display Panel – Tube Label

INfALAB®
MAGIC TOUCH

BraceRelief™
ANESTHETIC GEL IN AN ANTISEPTIC BASE
Relieves mouth pain
Net Wt. 3 g.
NDC#603061155

BRACE RELIEF 
benzocaine gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 60306-115
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Benzocaine (UNII: U3RSY48JW5) (Benzocaine - UNII:U3RSY48JW5)	Benzocaine	9 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
Polyethylene glycol 400 (UNII: B697894SGQ)
Polyethylene glycol 3350 (UNII: G2M7P15E5P)
Glycerin (UNII: PDC6A3C0OX)
Myrrh (UNII: JC71GJ1F3L)
Menthol (UNII: L7T10EIP3A)
Phenol (UNII: 339NCG44TV)
Clove Oil (UNII: 578389D6D0)
Methyl Salicylate (UNII: LAV5U5022Y)
Peppermint Oil (UNII: AV092KU4JH)
Methylparaben (UNII: A2I8C7HI9T)
Propylparaben (UNII: Z8IX2SC1OH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 60306-115-05	0.3 mL in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333B	01/03/2005

Labeler - InfaLab,Inc (967864141)

Registrant - PhytogenX,Inc. (010297942)

Establishment
Name	Address	ID/FEI	Business Operations
PhytogenX,Inc.		010297942	MANUFACTURE(60306-115)

Revised: 11/2013

Document Id: 390a5e15-64db-4873-b109-bc584f243923

Set id: d7e57d67-4234-44a9-bbd3-72e99cd5bdb3

Version: 1

Effective Time: 20131127