Drug Facts

Drug Facts
SPL v4
SPL
SPL Set ID fb9ddde3-3f40-467e-8aff-26570144f0fc
Route
TOPICAL
Published
Effective Date 2015-10-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lidocaine (2 g)
Inactive Ingredients
Carbomer Homopolymer Type C (allyl Pentaerythritol Crosslinked) Alcohol Ethylparaben Trolamine Glycerin Menthol, Unspecified Form Malondialdehyde Aloe Vera Leaf Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2015-10-30
Description

Active Ingredients Lidocaine 2.00 %

Medication Information

Warnings and Precautions

Warnings

. For external use only

Indications and Usage

   temporarily relieves pain, itching and irritation. Uses

Dosage and Administration

Directions

adults and children over 12 years of age:

-immediately after hair removal, apply sparingly and only to the

areas where it is needed

-Repeat as necessary, but no more than 4 times daily

-Continue to apply as a regular part of your hair removal routine,

whether you use a razor, wax or depilatory

Description

Active Ingredients Lidocaine 2.00 %

Section 44425-7

   store at room temperature 59 - 86 F Other information

(15 - 30 C)

Section 50565-1

. In case of accidental ingestion, get Keep out of reach of children

medical help or contact a Poison Control Center right away.

Section 50566-9

Stop use and ask a doctor if

-symptoms persist for more than 7 days or clear up and occur

again within a few days

-condition worsens

-redness is present

-irritation develops

Section 50567-7

When using this product

-avoid contact with eyes   -use only as directed

Section 50570-1

Do not use

-before any hair removal process that involves heat or lasers

-in large quantities, particularly over raw surfaces or

blistered areas

Section 51727-6

  aloe barbadensis leaf juice, carbomer Inactive Ingredients

940, ethyl alcohol, ethylparaben, glycerin, menthol, propanediol,

triethanolamine, water

Section 51945-4

Section 55105-1

Purpose

Topical analgesic

Section 55106-9

Active Ingredients

Lidocaine 2.00 %

Structured Label Content

Indications and Usage (34067-9)

   temporarily relieves pain, itching and irritation. Uses

Dosage and Administration (34068-7)

Directions

adults and children over 12 years of age:

-immediately after hair removal, apply sparingly and only to the

areas where it is needed

-Repeat as necessary, but no more than 4 times daily

-Continue to apply as a regular part of your hair removal routine,

whether you use a razor, wax or depilatory

Warnings and Precautions (34071-1)

Warnings

. For external use only

Section 44425-7 (44425-7)

   store at room temperature 59 - 86 F Other information

(15 - 30 C)

Section 50565-1 (50565-1)

. In case of accidental ingestion, get Keep out of reach of children

medical help or contact a Poison Control Center right away.

Section 50566-9 (50566-9)

Stop use and ask a doctor if

-symptoms persist for more than 7 days or clear up and occur

again within a few days

-condition worsens

-redness is present

-irritation develops

Section 50567-7 (50567-7)

When using this product

-avoid contact with eyes   -use only as directed

Section 50570-1 (50570-1)

Do not use

-before any hair removal process that involves heat or lasers

-in large quantities, particularly over raw surfaces or

blistered areas

Section 51727-6 (51727-6)

  aloe barbadensis leaf juice, carbomer Inactive Ingredients

940, ethyl alcohol, ethylparaben, glycerin, menthol, propanediol,

triethanolamine, water

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Purpose

Topical analgesic

Section 55106-9 (55106-9)

Active Ingredients

Lidocaine 2.00 %

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:01:42.642175 · Updated: 2026-03-14T23:01:30.191020