MENTHOL DAVIS ANALGESIC- menthol ointment
Genia Care Phamaceutical S.A.

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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Menthol Davis Topical Analgesic Ointment

Drug Facts

Active ingredient

Menthol 5%

Purpose

Topical Analgesic

Use

For the temporary relief of minor aches and pains of muscles and joints

Warnings

For external use only.

When using this product

avoid contact with the eyes
do not apply to wounds or damaged skin
do not bandage tightly

Stop use and ask a doctor if

condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days

Keep out of reach of children.

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

Directions

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

Other information

Store in a cool, dry, ventilated place, away from all sources of heat, ignition, and combustion.

Inactive ingredients

Paraffin wax, petrolatum.

Package Labeling:

Label

MENTHOL DAVIS ANALGESIC
menthol ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:82480-000
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	50 mg in 1 g

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

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:82480-000-01	1 in 1 BLISTER PACK	09/04/2023
1		28 g in 1 CAN; 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	09/04/2023

Labeler - Genia Care Phamaceutical S.A. (817305769)