PAIN RELIEF RUB- camphor,menthol, methyl salicylate cream

Pain Relief Rub by

Drug Labeling and Warnings

Pain Relief Rub by is a Otc medication manufactured, distributed, or labeled by Topco Associates LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Camphor 4%

Menthol 10%

Methyl Salicylate 30%

Uses

temporarily relieves the minor aches and pains of muscle and joints associated with: simple backache, arthritis, bruises, sprains

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
  

Ask a doctor before use if you have

redness over the affected area

When using this product

• avoid contact with eyes or mucous membranes
• do not bandage tightly
  

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
  

Keep out of reach of children to avoid accidental ingestion.

If swallowed, get medical help or contact a Poison Control Center immediately

Directions

• Use only as directed
• adults and children 12 years of age and older:

             apply to affected area not more than 3 to 4 times daily

• children under 12 years of age:  ask a doctor

Other information

• Store at 20° to 25°C (68°to 77°F)

Inactive Ingredients

carbomer940, cetyl alcohol, glyceryl monostearate, isopropyl myristate, polysorbate60, purified water, stearic acid, trolamine

PRINCIPAL DISPLAY PANEL

Pain Relief Rub

PURPOSE

Topical analgesic

Topical analgesic

Topical analgesic

INGREDIENTS AND APPEARANCE

PAIN RELIEF RUB 
camphor,menthol, methyl salicylate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 36800-042
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (Menthol - UNII:L7T10EIP3A)	MENTHOL	10 g  in 100 g
MENTHYL SALICYLATE, (+/-)- (UNII: 43XOA705ZD) (SALICYLIC ACID - UNII:O414PZ4LPZ)	MENTHYL SALICYLATE, (+/-)-	30 g  in 100 g
Camphor (Natural) (UNII: N20HL7Q941) (Camphor (Natural) - UNII:N20HL7Q941)	Camphor (Natural)	4 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
CARBOMER 940 (UNII: 4Q93RCW27E)
CETYL ALCOHOL (UNII: 936JST6JCN)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
POLYSORBATE 60 (UNII: CAL22UVI4M)
WATER (UNII: 059QF0KO0R)
STEARIC ACID (UNII: 4ELV7Z65AP)
TROLAMINE (UNII: 9O3K93S3TK)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 36800-042-04	1 in 1 BOX
1		114 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	09/01/2013

Labeler - Topco Associates LLC (006935977)