SPL v2
SPL
SPL Set ID 40ec5e6f-13dc-de04-e063-6294a90af5d5
Route
TOPICAL
Published
Effective Date 2026-02-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lidocaine (4 g)
Inactive Ingredients
Water Glycerin Hydroxyacetophenone Portulaca Grandiflora Whole Mentha Arvensis Leaf Edetate Disodium 1,2-hexanediol Chrysanthemum Indicum Top Propylene Glycol Carbomer Homopolymer, Unspecified Type Polyoxyl 40 Hydrogenated Castor Oil

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-10-12

Description

Active ingredient Lidocaine 4%


Medication Information

Warnings and Precautions

For external use only

Flammable: keep away from fire or flame

Indications and Usage

For the temporary relief of minor aches and pains of muscles and joints associated with: simple backache, arthritis, strains, bruises, sprains

Dosage and Administration

Directions

Adults and children 12 years and older: apply to affected area

not more than 3 to 4 times daily

Children under 12 years: ask a doctor

Description

Active ingredient Lidocaine 4%

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or

contact a Poison Control Center right away.

Section 50566-9

Stop use and ask a doctor if: condition worsens

symptoms persist for more than 7 days

symptoms clear up and occur again within a few days

Section 50567-7

When using this product: avoid contact with eyes,

mucous membranes do not bandage tightly

Section 50570-1

Do not use: on wounds or damaged skin with a heating pad

if allergic to menthol or any ingredient in this product

Section 51727-6

Water, Propylene Glycol, Carbomer Homopolymer, Glycerin,

Edetate Disodium, Hydroxyacetophenone, 1,2-Hexanediol,

Mentha Arvensis Leaf, Chrysanthemum Indicum Top,

Portulaca, Polyoxyl 40 Hydrogenated Castor Oil

Section 51945-4
Section 53414-9

If pregnant or breastfeeding, ask a health professional before use

Section 55105-1

Temporary relief of minor aches and pains

Section 55106-9

Active ingredient

Lidocaine 4%

Section 60561-8

Store at 15–30°C (59–86°F)

Protect from excessive moisture and direct sunlight

Keep the carton for full labeling


Structured Label Content

Indications and Usage (34067-9)

For the temporary relief of minor aches and pains of muscles and joints associated with: simple backache, arthritis, strains, bruises, sprains

Dosage and Administration (34068-7)

Directions

Adults and children 12 years and older: apply to affected area

not more than 3 to 4 times daily

Children under 12 years: ask a doctor

Warnings and Precautions (34071-1)

For external use only

Flammable: keep away from fire or flame

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or

contact a Poison Control Center right away.

Section 50566-9 (50566-9)

Stop use and ask a doctor if: condition worsens

symptoms persist for more than 7 days

symptoms clear up and occur again within a few days

Section 50567-7 (50567-7)

When using this product: avoid contact with eyes,

mucous membranes do not bandage tightly

Section 50570-1 (50570-1)

Do not use: on wounds or damaged skin with a heating pad

if allergic to menthol or any ingredient in this product

Section 51727-6 (51727-6)

Water, Propylene Glycol, Carbomer Homopolymer, Glycerin,

Edetate Disodium, Hydroxyacetophenone, 1,2-Hexanediol,

Mentha Arvensis Leaf, Chrysanthemum Indicum Top,

Portulaca, Polyoxyl 40 Hydrogenated Castor Oil

Section 51945-4 (51945-4)
Section 53414-9 (53414-9)

If pregnant or breastfeeding, ask a health professional before use

Section 55105-1 (55105-1)

Temporary relief of minor aches and pains

Section 55106-9 (55106-9)

Active ingredient

Lidocaine 4%

Section 60561-8 (60561-8)

Store at 15–30°C (59–86°F)

Protect from excessive moisture and direct sunlight

Keep the carton for full labeling


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)