PAIN RELIEVING BALM- menthol, methyl salicylate liquid

Pain Relieving Balm by

Drug Labeling and Warnings

Pain Relieving Balm by is a Otc medication manufactured, distributed, or labeled by TopCo, Product Quest mfg. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients                                        Purpose
Menthol 7.6%.............................................Topical Analgesic
Methyl Salicylate 29%.................................Topical Analgesic

PURPOSE

INDICATIONS & USAGE

Uses

temporarily relieves minor pain associated with:
arthritis simple backache muscle strains bruises
muscle sprains cramps

WARNINGS

Warnings
For external use only
Allergy Alert: If prone to allergic reaction from aspirin or
salicylates, consult a doctor before use.
When using this product use only as directed avoid
contact with eyes or mucous membranes do not bandage
tightly or use with a heating pad do not apply to wounds or
damaged skin
Stop use and ask doctor if condition worsens redness
is present irritation develops symptoms persist for more
than 7 days or clear up and occur again within a few days
If pregnant or breast-feeding, ask a healthcare professional
before use

Keep out of reach of children.

If swallowed get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION

Directions
Adults and children over 12 years: apply generously to
affected area massage into painful area until
thoroughly absorbed into skin repeat as
necessary, but not more than 4 times daily.
Children under 12 years: ask a doctor

INACTIVE INGREDIENT

Inactive ingredients
Paraffin, White Petrolatum

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

PAIN RELIEVING BALM 
menthol, methyl salicylate liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 36800-738
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Menthol (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	Menthol	7.6 g  in 100 g
Methyl Salicylate (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	Methyl Salicylate	29 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
Paraffin (UNII: I9O0E3H2ZE)
PETROLATUM (UNII: 4T6H12BN9U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 36800-738-04	99.2 g in 1 PACKAGE; Type 0: Not a Combination Product	11/16/2011

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	11/16/2011

Labeler - TopCo (006935977)

Registrant - Product Quest mfg (927768135)

Establishment
Name	Address	ID/FEI	Business Operations
Product Quest mfg		927768135	manufacture(36800-738) , label(36800-738)