Atopalm Moisturizing Muscle Rub
FDA Label NDC 51141-5000

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 Moisturizing Muscle Rub (NDC 51141-5000). 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 - do not use, otc - ask doctor, otc - when using, 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 - Do Not Use

→ Otc - Ask Doctor

→ Otc - When Using

→ Otc - Stop Use

→ Otc - Keep Out Of Reach Of Children

→ Dosage & Administration

→ Storage And Handling

→ Inactive Ingredient

→ Otc - Questions

→ Package Label.principal Display Panel

Other

Drug Facts

US Patent US 6221371B1

Distributed by: NeoPharm Co., Ltd, 80 Wood Rd, 212 Camarillo, CA 93010

Made in Korea

3 Pain Relievers

Moisturizing

Muscle Rub Cream

Otc - Active Ingredient

Active Ingredients

Camphor 4%

Menthol 10%

Methyl Salicylate 30%

Otc - Purpose

Purpose

Topical Analgesic

Indications & Usage

Uses temporarily relieves the minor aches and pains of muscles and joints associated with:

simple backache
arthritis
strains
bruises
sprains

Warnings

Warnings For external use only.

Otc - Do Not Use

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 - Ask Doctor

Ask a doctor before use if you 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 - Stop Use

Stop use and ask a doctor if

condition worsens or symptoms persist for more than 7 days
symptoms clear up and occur again within a few days
excessive skin irritation occurs

Otc - Keep Out Of Reach Of Children

Keep out of reach of children to avoid accidental ingestion. If swallowed, get medical help or contact a Poison Control Center immediately.

Dosage & Administration

Directions

use only as directed
adults and children 12 years of age or older: apply to affected area not more than 3 to 4 times daily
children under 12 years of age: ask a doctor

Storage And Handling

Other Information

store at 20 degrees to 25 degrees (68 degrees to 77 degrees F)

Inactive Ingredient

Inactive Ingredients

Water, Cetyl Alcohol, Polysorbate 60, Glyceryl Stearate, Isopropyl Myristate, Stearic Acid, Carbomer 940, Cholesterol, Myristoyl/Palmitoyl Oxostearamide/Arachamide MEA, Triethanolamine