Atopalm Pain Relieving
FDA Label NDC 51141-0239

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Neopharm Co., Ltd. for the product Atopalm Pain Relieving (NDC 51141-0239). 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 other, otc - active ingredient, otc - purpose, indications & usage, warnings, otc - stop use, otc - when using, 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

→ Other

→ Otc - Active Ingredient

→ Otc - Purpose

→ Indications & Usage

→ Warnings

→ Otc - Stop Use

→ Otc - When Using

→ Otc - Keep Out Of Reach Of Children

→ Dosage & Administration

→ Inactive Ingredient

→ Storage And Handling

→ Otc - Questions

→ Package Label.principal Display Panel

Other

Drug Facts

US Patent # US 6221371B1

Distributed by: NeoPharm USA, 1 Oyster Bay Drive, Rumson, NJ 07760

Made in Korea

Otc - Active Ingredient

Active ingredient

Menthol 10%

Otc - Purpose

Purpose

Topical Analgesic

Indications & Usage

Uses For temporary relief of minor aches and pains of muscles and joints associated with

simple backache
arthritis
strains
bruises
sprains

Warnings

Warnings For external use only.

Do not use

on wounds or damaged skin
with a heating pad
on a child under 12 years of age with arthritis like conditions

Otc - Stop Use

Stop use and ask a doctor if

conditions worsen
symptoms persist for more than 7 days
symptoms clear up and occur again within a few days
excessive skin irritation occurs
have redness over the affected area.

Otc - When Using

When using this product avoid contact with eyes or mucous membranes, do not bandage tightly.

Otc - Keep Out Of Reach Of Children

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

Dosage & Administration

Directionsadults and children 12 years of age and olderapply to affected area not more than 3 to 4 times dailyChildren under 12 years of ageask a doctor

Inactive Ingredient

Inactive Ingredients

WATER, GLYCERIN, CETYL ALCOHOL, POLYSORBATE 60, GLYCERYL STEARATE, STEARIC ACID, DIMETHICONE, ISOPROPYL MYRISTATE, MYRISTOYL/PALMITOYL OXOSTEARAMIDE/ARACHAMIDE MEA, CARBOMER, TRIETHANOLAMINE, CHOLESTEROL, ALOE VERA GEL, METHYLPARABEN, PROPYLPARABEN.