SPL v12
SPL
SPL Set ID d7e57d67-4234-44a9-bbd3-72e99cd5bdb3
Route
ORAL
Published
Effective Date 2022-03-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzocaine (9 mg)
Inactive Ingredients
Polyethylene Glycol 400 Polyethylene Glycol 3350 Glycerin Myrrh Menthol Phenol Clove Oil Methyl Salicylate Peppermint Oil Methylparaben Propylparaben

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2005-01-03
Description

Benzocaine 9%

Medication Information

Indications and Usage

 

Description

Benzocaine 9%

Section 50565-1

 

Section 51945-4

Principal Display Panel – Tube Label

INfALAB®

MAGIC TOUCH

BraceRelief ™

ANESTHETIC GEL IN AN ANTISEPTIC BASE

Relieves mouth pain

Net Wt. 3 g.

NDC#603061155

Section 55105-1

 

Caution:

For temporary relief only.

Dist.by Infa-Lab Inc., Rockaway, NJ 07866

1996 INFA-LAB INC., Rockaway, NJ

Directions:

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

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.

Structured Label Content

Indications and Usage (34067-9)

 

Section 50565-1 (50565-1)

 

Section 51945-4 (51945-4)

Principal Display Panel – Tube Label

INfALAB®

MAGIC TOUCH

BraceRelief ™

ANESTHETIC GEL IN AN ANTISEPTIC BASE

Relieves mouth pain

Net Wt. 3 g.

NDC#603061155

Section 55105-1 (55105-1)

 

Caution: (CAUTION:)

For temporary relief only.

Dist.by Infa-Lab Inc., Rockaway, NJ 07866

1996 INFA-LAB INC., Rockaway, NJ

Directions: (DIRECTIONS:)

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

Active Ingredients: (ACTIVE INGREDIENTS:)

Benzocaine 9%

Inactive Ingredients: (INACTIVE INGREDIENTS:)

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

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:08:18.620825 · Updated: 2026-03-14T23:12:31.383435