Satohap Lidocaine Hcl 4% Pain Relieving Lotion

SPL v4

SPL

SPL Set ID f7faddb2-5153-4fdd-a5ef-778182cef460

Route

TOPICAL

Published

Effective Date 2018-11-19

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Inactive Ingredients

Alcohol Propylene Glycol Sodium Hydroxide Water

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2018-11-19

Description

Active ingredients Lidocaine hydrochloride 4%

Medication Information

Warnings and Precautions

Warnings

For external use only

Flammable: Keep away from fire and flame

Indications and Usage

Uses

For temporary relief of pain and itching

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 hydrochloride 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
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 alcohol, propylene glycol, sodium hydroxide, water

Section 51945-4

Section 55105-1

Purpose

Lidocaine hydrochloride - Topical analgesic

Section 55106-9

Active ingredients

Lidocaine hydrochloride 4%

Section 60561-8

Other information

avoid storing in direct sunlight
store with lid tightly closed

Structured Label Content

Indications and Usage (34067-9)

Uses

For temporary relief of pain and itching

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

Flammable: Keep away from fire and 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
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 alcohol, propylene glycol, sodium hydroxide, water

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Purpose

Lidocaine hydrochloride - Topical analgesic

Section 55106-9 (55106-9)

Active ingredients

Lidocaine hydrochloride 4%

Section 60561-8 (60561-8)

Other information

avoid storing in direct sunlight
store with lid tightly closed

Advanced Ingredient Data

[{"name": "ALCOHOL", "unii": "3K9958V90M", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PROPYLENE GLYCOL", "unii": "6DC9Q167V3", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM HYDROXIDE", "unii": "55X04QC32I", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "LIDOCAINE HYDROCHLORIDE ANHYDROUS", "unii": "EC2CNF7XFP", "classCode": "ACTIR", "strengthNumerator": "4", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}]

Raw Label Data

All Sections (JSON)

{"34067-9": "Uses For temporary relief of pain and itching", "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", "34071-1": "Warnings For external use only Flammable: Keep away from fire and flame", "50565-1": "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.", "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", "50567-7": "When using this product avoid contact with the eyes", "50570-1": "Do not use in large quantities, particularly over raw surfaces or blistered areas", "51727-6": "Inactive ingredients alcohol, propylene glycol, sodium hydroxide, water", "55105-1": "Purpose Lidocaine hydrochloride - Topical analgesic", "55106-9": "Active ingredients Lidocaine hydrochloride 4%", "60561-8": "Other information avoid storing in direct sunlight store with lid tightly closed"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:05:14.449170 · Updated: 2026-03-14T23:06:44.003626