REXALL VANISHING SCENT PAIN RELIEVING- menthol gel

Rexall Vanishing Scent Pain Relieving by

Drug Labeling and Warnings

Rexall Vanishing Scent Pain Relieving by is a Otc medication manufactured, distributed, or labeled by DOLGENCORP, LLC, Pharma Pac, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient                                 Purpose

Menthol 2.5%.................................................Topical Analgesic

PURPOSE

Uses temporarily relieves the minor aches and pains of muscles and joints associated with
- simple backache - atrhritis - strains - bruises - sprains

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed, get medical help or contact a
Poison Control Center right away.

INDICATIONS & USAGE

Uses temporarily relieves the minor aches and pains of muscles and joints associated with
- simple backache - atrhritis - strains - bruises - sprains

WARNINGS

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

DOSAGE & ADMINISTRATION

Directions

Adults and children 12 years of age and older - apply to the affected area not more than 3 to 4
times daily.

Children under 12 years of age - consult a doctor

INACTIVE INGREDIENT

Inactive Ingredients


purified water, isopropyl alcohol, potassium hydroxide, non0xynol-9, carbomer, camphor, diazolidinyl urea

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

REXALL VANISHING SCENT PAIN RELIEVING 
menthol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55910-602
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	27.5 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CARBOMER 934 (UNII: Z135WT9208)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)
NONOXYNOL-9 (UNII: 48Q180SH9T)
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55910-602-04	1 in 1 CARTON
1		57 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	03/14/2011

Labeler - DOLGENCORP, LLC (068331990)

Registrant - Pharma Pac, LLC (140807475)

Establishment
Name	Address	ID/FEI	Business Operations
Pharma Pac, LLC		140807475	manufacture