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PAIN BUST R II

Dosage form: cream
Ingredients: MENTHOL 12g in 100g, METHYL SALICYLATE 18g in 100g
Labeler: CCA Industries, Inc.
NDC Code: 61543-3130

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

PAIN BUST R II

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.

PurposeTopical analgesic

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

Specially formulated for Arthritis Pain Relief!   Puts Pain To SLEEP  Pinpoints and Attacks Pain Fast    Reduces Stiffness Associated with Arthritis Flare-ups

PAIN 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

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PAIN BUST R II 
menthol, methyl salicylate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61543-3130
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (MENTHOL) MENTHOL12 g  in 100 g
METHYL SALICYLATE (METHYL SALICYLATE) METHYL SALICYLATE18 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
CETETH-2 
DIETHANOLAMINE CETYL PHOSPHATE 
GLYCERYL MONOSTEARATE 
PEG-40 STEARATE 
STEARIC ACID 
STEARYL ALCOHOL 
WATER 
Packaging
#Item CodePackage Description
1NDC:61543-3130-31 JAR (JAR) in 1 CARTON
185 g in 1 JAR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34812/23/2011
Labeler - CCA Industries, Inc. (106771041)
Establishment
NameAddressID/FEIOperations
Suite K Value Added Services LLC036822144manufacture

Revised: 12/2011
 
CCA Industries, Inc.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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