Pain Bust R Ii
FDA Label NDC 61543-3130

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Cca Industries, Inc. for the product Pain Bust R Ii (NDC 61543-3130). 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 active ingredients, use, warnings, when using this product, stop use and ask a doctor if, if pregnant or breast-feeding,, keep out of reach of children, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Active Ingredients

→ Use

→ Warnings

→ When Using This Product

→ Stop Use And Ask A Doctor If

→ If Pregnant Or Breast-feeding,

→ Keep Out Of Reach Of Children

→ Directions

→ Inactive Ingredients

→ Other Information

→ Questions Or Comments?

→ Purpose

→ Description

→ Package Label.principal Display Panel

→ Outer Package 1

→ Outer Package 2

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→ Outer Package 5

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Active Ingredients

Active Ingredients Purpose

Menthol 12.00% ....................................Topical Analgesic

Methyl Salicylate 17.00% .....................Topical Analgesic

Use

Temporarily relieves minor pain associated with arthritis

Warnings

For external use only

Allergy alert: Do not use if you are allergic to salicylates (including aspirin) unless directed by a doctor.

When Using This Product

- Use only as directed - Do not bandage tightly or use a heating pad - Avoid contact with eyes or mucous membranes - Do not apply to wounds or damaged skin

Stop Use And Ask A Doctor If

Condition worsens
Symptoms persist for more than 7 days or clear up and occur again within a few days
Redness is present
Irritation develops

If Pregnant Or Breast-Feeding,

ask a health professional before use.

Keep Out Of Reach Of Children

In case of accidental ingestion, get medical help or contact a Poison Control Center right away.

Directions

adults and children over 17 years
apply generously to affected area; massage into painful area until thoroughly absorbed into skin; repeat as necessary but no more than 4 times daily

children 17 years or younger
do not use without asking a doctor

Inactive Ingredients

Ceteth-2, Cetyl Alcohol, DEA-Cetyl Phosphate, Emulsifying Wax, Glyceryl Stearate SE, PEG-40 Stearate, Stearic Acid, Stearyl Alcohol, Water (Aqua).

Other Information

Store in a cool palce

Questions Or Comments?

Call 1-800-595-6230 Report any issues associated with this product to the telephone number or address listed on this package.

Purpose

Topical analgesic

Description

EXTRA STRENGTH PAIN BUST RII Penetrating Arthritis Pain Relief Cream MONEY BACK GUARANTEE Complete details available at www.PainBustRII.com or call 1-800-595-6230 ext. 175 Pinpoints and Attacks Arthritis Pain Fast Provides Warming Relief for Aches, Pain and Soreness Made in U.S.A. Printed in U.S.A. INDICATIONS: Brings quick, temporary relief of minor pain associated with arthritis. In order to obtain an accurate diagnosis and then comprehensive management plan including medications, exercise, weight control or other techniques, we advise you to seek a medical confirmation. For more information visit www.PainBustRII.com Puts Pain To Sleep -Greaseless -Stainless

Package Label.Principal Display Panel

Specially formulated for Arthritis Pain Relief! Puts Pain To SLEEP Pinpoints and Attacks Pain Fast Reduces Stiffness Associated with Arthritis Flare-upsPAIN BUST RII PENETRATING ARTHRITIS PAIN RELIEF CREAM Greaseless Stainless

-Greaseless -Stainless EXTRA STRENGTH PAIN BUST RII Penetrating Arthritis Pain Relief Cream MONEY BACK GUARANTEE Complete details available at www.PainBustRII.com Net Wt. 3oz(85g)

Enjoy Life the Way It Used to Be-- FREE FROM ARTHRITIS PAIN!*

EXTRA STRENGTH PAIN BUST RII Penetrating Arthritis Pain Relief Cream MONEY BACK GUARANTEE Complete details available at www.PainBustRII.com or call 1-800-595-6230 ext. 175 Specially formulated for Arthritis Pain Relief

Specially formulated for Arthritis Pain Relief EXTRA STRENGTH PAIN BUST RII Penetrating Arthritis Pain Relief Cream Pinpoints and Attacks Pain Fast Reduces Stiffness Associated with Arthritis Flare-ups -Greaseless -Stainless Puts Pain To SLEEP Net Wt. 3 oz (85g)

EXTRA STRENGTH PAIN BUST R II PAIN RELIEF CREAM -Greaseless -Stainless Temporary relief from: -Arthritis -Bursitis -Joint Pain -Back and Body Aches -Muscle Strains and Sprains Manufactured in the USA for: CCA Industries, Inc. 200 Murray Hill Pkwy., E. Rutherford, NJ 07073 USA 33130 03-3 1-800-595-6230