PAIN BUST R II- menthol, methyl salicylate cream

PAIN BUST R II by

Drug Labeling and Warnings

PAIN BUST R II by is a Otc medication manufactured, distributed, or labeled by CCA Industries, Inc., Suite K Value Added Services LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredients

Menthol 12.00%

Methyl Salicylate 17.00%

Purpose

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.

Package Labeling:

INGREDIENTS AND APPEARANCE

PAIN BUST R II 
menthol, methyl salicylate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61543-3130
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	12 g  in 100 g
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	METHYL SALICYLATE	17 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
CETETH-2 (UNII: 7H8VAM7778)
DIETHANOLAMINE CETYL PHOSPHATE (UNII: 4UG0316V9S)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
PEG-40 STEARATE (UNII: ECU18C66Q7)
STEARIC ACID (UNII: 4ELV7Z65AP)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61543-3130-3	1 in 1 CARTON	12/23/2011
1		85 g in 1 JAR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	12/23/2011

Labeler - CCA Industries, Inc. (106771041)

Establishment
Name	Address	ID/FEI	Business Operations
Suite K Value Added Services LLC		036822144	manufacture(61543-3130)