Satohap Lidocaine 4% Menthol 1% Pain Relieving Cream
FDA Label NDC 49873-619

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Sato Pharmaceutical Co., Ltd. for the product Satohap Lidocaine 4% Menthol 1% Pain Relieving Cream (NDC 49873-619). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - when using, otc - stop use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Active ingredients

Lidocaine 4%

Menthol 1%

Otc - Purpose

Purpose

Lidocaine  Topical analgesic

Menthol   Topical analgesic

Indications & Usage

Uses

For temporary relief of pain

Warnings

Warnings

For external use only

Otc - Do Not Use

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

Otc - When Using

When using this product avoid contact with the eyes

Otc - Stop Use

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

Otc - Keep Out Of Reach Of Children

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

Dosage & 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

Other Safety Information

Other information

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

Inactive Ingredient

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

Package Label.Principal Display Panel

Pdp (Lidocrpdp)

Pdp (Lidocrpdp)

Carton (Lidocrcart)

Carton (Lidocrcart)

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