MEN-PHOR- menthol, camphor lotion
Geritrex LLC

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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Men-Phor

Drug Facts

Active Ingredients Purpose
0.5% Camphor . . . .Anti-Infective, Anti-Pruritic
0.5% Menthol . . . .Anti-Pruritic

Uses

To provide temporary relief for dry
itching skin, sunburn, insect bites and pruritus.

Directions

• Apply two or three times daily, or as directed
by your physician.

Warnings

For External Use Only
• Avoid contact with eyes. If contact occurs,
rinse eyes thoroughly with water.
• If improvement does not occur, or condition
worsens after regular use as directed,
discontinue use and consult a physician.
• Do not use on children under two years of age.
• Do not apply under compresses or bandages

Other Ingredient

Alcohol, Carbomers, Cetyl Alcohol, DMDM Hydantoin, Fragrance, Glycerin, Glycol Stearate, Methylparaben, PEG-200 Dilaurate, PEG-40 Hydrogenated Castor Oil, Petrolatum, Propylparaben, Stearic Acid, Trolamine, Water

Keep out of reach of children

Apply two or three times daily.

image description

MEN-PHOR
menthol, camphor lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:54162-550
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	1.11 g in 222 mL
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET)	CAMPHOR (SYNTHETIC)	1.11 g in 222 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)
STEARIC ACID (UNII: 4ELV7Z65AP)
CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)
CETYL ALCOHOL (UNII: 936JST6JCN)
DMDM HYDANTOIN (UNII: BYR0546TOW)
GLYCOL STEARATE (UNII: 0324G66D0E)
PEG-200 DILAURATE (UNII: TWV5J70L88)
PEG-40 CASTOR OIL (UNII: 4ERD2076EF)
PETROLATUM (UNII: 4T6H12BN9U)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
TROLAMINE (UNII: 9O3K93S3TK)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:54162-550-07	222 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	07/31/2015
2	NDC:54162-550-02	59 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/31/2015
3	NDC:54162-550-09	222 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product	07/31/2015

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	07/31/2015

Labeler - Geritrex LLC (112796248)

Name	Address	ID/FEI	Business Operations
Establishment
Geritrex LLC		112796248	manufacture(54162-550)