SPL v1
SPL
SPL Set ID 445db02a-c8e8-6ebb-e063-6294a90a4301
Route
TOPICAL
Published
Effective Date 2025-11-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzyl Alcohol (10 g)
Inactive Ingredients
1,2-hexanediol Caprylyl Glycol Edetate Disodium Maltodextrin Propylene Glycol Hydroxyethylcellulose Isopropyl Alcohol Vanillyl Butyl Ether Ginger Bisabolol Aloe Barbadensis Leaf Juice Aminomethylpropanol Polyacrylate Crosspolymer-6 Alcohol Water

Identifiers & Packaging

Pill Appearance
Shape: round
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-11-15

Description

Benzyl alcohol 10% Lidocaine HCl 4%


Medication Information

Warnings and Precautions

For external use only

Flammable keep away from heat and open flame

Do not use

  • in large quantities
  • on wounds, damaged, broken, or irritated skin
  • for more than one week without consulting a doctor

When using this product

  • use only as directed. Read and follow all directions and warnings on this label
  • avoid contact with the eyes and mucous membranes
  • do not bandage tightly or apply local heat such as a heating pad or a medicated patch
  • do not use with other topical analgesics

Stop use and ask a doctor if

  • rash or irritation develops
  • symptoms worsen or persist for more than 7 days or clear up and occur again within a few days

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Indications and Usage

Use for the temporary relief of pain

Dosage and Administration

Benzyl alcohol 10%

Lidocaine HCl 4%

Description

Benzyl alcohol 10% Lidocaine HCl 4%

Section 50565-1

Directions

  • adults and children 2 years of age and older: apply to affected area no more than 3 to 4 times daily
  • children under 2 years of age: consult a doctor before use.
Section 50567-7
  • adults and children 2 years of age and older: apply to the affected area no more than 3 to 4 times daily
  • children under 2 years of age: consult a doctor before use
Section 51727-6

1, 2 hexanediol

alcohol

aloe barbadensis leaf juice

aminomethyl propanol

bisabolol

caprylyl glycol

disodium EDTA

hydroxyethylcellulose

isopropyl alcohol

maltodextrin

polyacrylate crosspolyer-6

propylene glycol

vanillyl butyl ether

water

zingiber officinale (ginger) root extract

Section 51945-4

NEW!

ThermaCare Heat Therapy

Soothing Heat 2x Dual Action Maximum Lidocaine

Heat + Max Strength Lidocaine Pain Relief

Fast Acting, Long Lasting

Penetrates to the Source

#1 Doctor Recommended

Gel NET WT 3 OZ (85g)

Non Greasy Vanishing Scent

Distributed by:

Bridges Consumer Healthcare

811 Broad Street, Suite 600

Chattanooga, TN 37402 2026

Section 53413-1

1-800-323-3383

Section 55105-1

Topical anesthetic

Section 55106-9

Benzyl alcohol 10%

Lidocaine HCl 4%


Structured Label Content

Indications and Usage (34067-9)

Use for the temporary relief of pain

Dosage and Administration (34068-7)

Benzyl alcohol 10%

Lidocaine HCl 4%

Warnings and Precautions (34071-1)

For external use only

Flammable keep away from heat and open flame

Do not use

  • in large quantities
  • on wounds, damaged, broken, or irritated skin
  • for more than one week without consulting a doctor

When using this product

  • use only as directed. Read and follow all directions and warnings on this label
  • avoid contact with the eyes and mucous membranes
  • do not bandage tightly or apply local heat such as a heating pad or a medicated patch
  • do not use with other topical analgesics

Stop use and ask a doctor if

  • rash or irritation develops
  • symptoms worsen or persist for more than 7 days or clear up and occur again within a few days

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50565-1 (50565-1)

Directions

  • adults and children 2 years of age and older: apply to affected area no more than 3 to 4 times daily
  • children under 2 years of age: consult a doctor before use.
Section 50567-7 (50567-7)
  • adults and children 2 years of age and older: apply to the affected area no more than 3 to 4 times daily
  • children under 2 years of age: consult a doctor before use
Section 51727-6 (51727-6)

1, 2 hexanediol

alcohol

aloe barbadensis leaf juice

aminomethyl propanol

bisabolol

caprylyl glycol

disodium EDTA

hydroxyethylcellulose

isopropyl alcohol

maltodextrin

polyacrylate crosspolyer-6

propylene glycol

vanillyl butyl ether

water

zingiber officinale (ginger) root extract

Section 51945-4 (51945-4)

NEW!

ThermaCare Heat Therapy

Soothing Heat 2x Dual Action Maximum Lidocaine

Heat + Max Strength Lidocaine Pain Relief

Fast Acting, Long Lasting

Penetrates to the Source

#1 Doctor Recommended

Gel NET WT 3 OZ (85g)

Non Greasy Vanishing Scent

Distributed by:

Bridges Consumer Healthcare

811 Broad Street, Suite 600

Chattanooga, TN 37402 2026

Section 53413-1 (53413-1)

1-800-323-3383

Section 55105-1 (55105-1)

Topical anesthetic

Section 55106-9 (55106-9)

Benzyl alcohol 10%

Lidocaine HCl 4%


Advanced Ingredient Data


Raw Label Data

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