Analgesic Balm by Geritrex LLC ANALGESIC BALM ointment

Analgesic Balm by

Drug Labeling and Warnings

Analgesic Balm by is a Otc medication manufactured, distributed, or labeled by Geritrex LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Menthol-6%, Methyl Salicylate-14%
Purpose: External analgesic

Uses

For the temporary relief of
minor aches and pain of muscles
and joints.

Directions

Adults and children
2 years of age and older: Apply
generously to affected area not
more than 3 to 4 times daily.
Children under 2 years of age:
Consult a doctor.

DOSAGE & ADMINISTRATION

Apply generously to affected area not
more than 3 to 4 times daily.
Children under 2 years of age:
Consult a doctor.

WARNINGS

Avoid contact with eyes or
mucous membranes. Discontinue
use if excessive irritation of the
skin develops.
Do not: bandage tightly; apply
to wounds, damaged skin, or
use with a heating pad.
If condition worsens, or if
symptoms persist more than
7 days or clear-up and reoccur
again within a few days,
discontinue use of this product
and consult a doctor. If
swallowed, get medical help
or contact a Poison Control
Center immediately.

INACTIVE INGREDIENT

Acylates Copolymer, DMDM Hydantoin,
Lanolin, Paraffin Wax,
Peg-40 Hydrogenated Castor Oil,
Petrolatum, Phenoxyethanol, Water.

STORAGE

At room temperature
20º-25º C (68º-77º F). Close cap
tightly after use.

OTC - KEEP OUT OF REACH OF CHILDREN

Children under 2 years of age:
Consult a doctor.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ANALGESIC BALM 
analgesic balm ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54162-555
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	1.74 g  in 29 g
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	METHYL SALICYLATE	4.06 g  in 29 g

Inactive Ingredients
Ingredient Name	Strength
DMDM HYDANTOIN (UNII: BYR0546TOW)
WATER (UNII: 059QF0KO0R)
LANOLIN (UNII: 7EV65EAW6H)
PARAFFIN (UNII: I9O0E3H2ZE)
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)
PETROLATUM (UNII: 4T6H12BN9U)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CARBOMER COPOLYMER TYPE A (UNII: 71DD5V995L)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54162-555-01	29 g in 1 TUBE; Type 0: Not a Combination Product	07/31/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	03/09/2012

Labeler - Geritrex LLC (112796248)

Establishment
Name	Address	ID/FEI	Business Operations
Geritrex LLC		112796248	manufacture(54162-555)