FAMILY CARE MENTHOL RELIEF- menthol and methyl salicylate stick
UNITED EXCHANGE CORP.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Active Ingredients Purpose

Menthol 4%............................................................................Topical analgesic

Methyl salicylate 1%................................................................Topical analgesic

Uses

For the temporary relief of minor discomforts of muscles and joints associated with simple backache, arthritis, strains, bruises, sprains.

Warnings

For external use only.

If pregnant or breast-feeding, ask a health professional before use.

Do not use if allergic to salicylates (including aspirin) without consulting a physician.

When using this product use only as directed, do not bandage tightly or use with a heating pad, avoid contact with eyes and mucous membranes, do not apply to wounds or damaged skin.

Stop use and ask a doctor if

conditions worsens, symptoms persist for more than 7 days or clear up and occur again within a few days, redness is present, irritation develops.

Keep out of reach of children.

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

Directions

Adults and Children 10 Years of Age and Older

Apply generously to affected area
Massage into area until thoroughly absorbed into skin
Repeat as necessary, but no more than 4 times daily

Children Under 10 Years of Age Consult a docotor

Inactive ingredients

Ethyl alcohol, Hydrogenated Castor Oil, PEG-150 Distearate, Propylene Glycol, Sodium Stearate, Water

Distributed by:

United Exchange Corp.

17211 Valley View Ave.

Cerritos, CA 90703 USA

Made in China

image description

FAMILY CARE MENTHOL RELIEF
menthol, methyl salicylate stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:65923-902
Route of Administration	TOPICAL	DEA Schedule

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	4 g in 100 g
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	METHYL SALICYLATE	1 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
ALCOHOL (UNII: 3K9958V90M)
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)
PEG-150 DISTEARATE (UNII: 6F36Q0I0AC)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SODIUM STEARATE (UNII: QU7E2XA9TG)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:65923-902-57	57 g in 1 APPLICATOR; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	03/01/2012	02/10/2016

Labeler - UNITED EXCHANGE CORP. (840130579)

Revised: 2/2016

Document Id: dc5cc5dd-8c7b-4055-8c6e-2884051c2d26

Set id: a9f50164-210c-4f1e-b967-7b7caabaa8db

Version: 4

Effective Time: 20160212

UNITED EXCHANGE CORP.