PAIN RELIEVING- menthol gel

Pain Relieving by

Drug Labeling and Warnings

Pain Relieving by is a Otc medication manufactured, distributed, or labeled by Cardinal Health, Span Packaging Services LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredients

Active Ingredients                   
Menthol 3.5%

Purpose

Cooling Pain Relief

Uses

Temporary relief from minor aches and pains of sore muscles and joints associated with arthritis backache strains sprains

Warnings:

For external use only

Ask a doctor before use if you have:

sensitive skin, are pregnant or breast feeding

When Using This Product:

Avoid contact with eyes or mucous membranes

Do not apply to wounds, damaged or irritated skin, or if excessive irritation develops

Do not bandage or use with heating pad or device. ointments, creams, sprays. liniments

Wash hands after with cool water

Stop Use And Ask A Doctor If:

Condition worsens. symptoms persist more than 7 days, or clear up and recur

Keep out of reach of children:

If ingested, get medical help. Contact Poison Control Center immediately.

Directions:

Adults / Children 2 years and older: Massage onto affected area up to 4 times daily.  Children under 2 years of age: Consult physician

Other Information:

Store in cool dry place, lid closed tightly. keep away from excessive heat or open flame.

Inactive Ingredients:

Water, isopropyl alcohol, herbal extract (IIex paraguariensis), menthol, carbomer, triethanolamine, silicon dioxide, methylparaben, glycerine, propylene glycol, FDandC blue #1

Package Labeling:

INGREDIENTS AND APPEARANCE

PAIN RELIEVING 
menthol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 37205-824
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	35 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
TROLAMINE (UNII: 9O3K93S3TK)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
METHYLPARABEN (UNII: A2I8C7HI9T)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 37205-824-26	1 in 1 CARTON	01/18/2012
1		118 mL in 1 BOTTLE; 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	01/18/2012

Labeler - Cardinal Health (097537435)

Establishment
Name	Address	ID/FEI	Business Operations
Span Packaging Services LLC		117101131	manufacture(37205-824)

Establishment
Name	Address	ID/FEI	Business Operations
Span Packaging Services LLC		557434805	manufacture(37205-824)