Satohap Lidocaine 4% Menthol 1% Cream

Satohap Lidocaine 4% Menthol 1% Cream
SPL v3
SPL
SPL Set ID 2251e96b-d050-4ec2-a6b9-6659610885bf
Route
TOPICAL
Published
Effective Date 2018-11-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lidocaine (4 g) Levomenthol (1 g)
Inactive Ingredients
Benzyl Alcohol Butylene Glycol Carbomer Homopolymer Type C Isopropyl Myristate Polyoxyl 40 Hydrogenated Castor Oil Sodium Hydroxide Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2018-11-14
Description

Active ingredients Lidocaine 4% Menthol 1%

Medication Information

Warnings and Precautions

Warnings

For external use only

Indications and Usage

Uses

For temporary relief of pain

Dosage and Administration

Directions

  • adults and children 12 years of age and older: apply to affected area not more than 3 to 4 times dailly
  • children under 12 years of age: do not use, ask a doctor
Description

Active ingredients Lidocaine 4% Menthol 1%

Image

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
  • a rash or irritation develops
Section 50567-7

When using this product avoid contact with the eyes

Section 50570-1

Do not use in large quantities, particularly over raw surfaces or blistered areas

Section 51727-6

Inactive ingredients  benzyl alcohol, butylene glycol, carbomer homopolymer (type C), isopropyl myristate, polyoxyl 40 hydrogenated castor oil, sodium hydroxide, water

Section 55105-1

Purpose

Lidocaine  Topical analgesic

Menthol   Topical analgesic

Section 55106-9

Active ingredients

Lidocaine 4%

Menthol 1%

Section 60561-8

Other information

  • protect product from excessive moisture
  • avoid storing in direct sunlight
  • store with lid tightly closed

Structured Label Content

Image

Indications and Usage (34067-9)

Uses

For temporary relief of pain

Dosage and Administration (34068-7)

Directions

  • adults and children 12 years of age and older: apply to affected area not more than 3 to 4 times dailly
  • children under 12 years of age: do not use, ask a doctor
Warnings and Precautions (34071-1)

Warnings

For external use only

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
  • a rash or irritation develops
Section 50567-7 (50567-7)

When using this product avoid contact with the eyes

Section 50570-1 (50570-1)

Do not use in large quantities, particularly over raw surfaces or blistered areas

Section 51727-6 (51727-6)

Inactive ingredients  benzyl alcohol, butylene glycol, carbomer homopolymer (type C), isopropyl myristate, polyoxyl 40 hydrogenated castor oil, sodium hydroxide, water

Section 55105-1 (55105-1)

Purpose

Lidocaine  Topical analgesic

Menthol   Topical analgesic

Section 55106-9 (55106-9)

Active ingredients

Lidocaine 4%

Menthol 1%

Section 60561-8 (60561-8)

Other information

  • protect product from excessive moisture
  • avoid storing in direct sunlight
  • store with lid tightly closed

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:05:08.154044 · Updated: 2026-03-14T23:06:30.937806