MENTICOL FIRST AID ANTISEPTIC AND EXTERNAL ANALGESIC LOTION- menthol , alcohol lotion

Menticol first aid antiseptic and external analgesic lotion by

Drug Labeling and Warnings

Menticol first aid antiseptic and external analgesic lotion by is a Otc medication manufactured, distributed, or labeled by Perfumeria Lemaitre S.A.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Drug Facts

Active Ingredient                           Purposes

Menthol 0.39 percent                     External Analgesic

Ethyl Alcohol 70 percent               Antiseptic

PURPOSE

Uses

For the temporary relief of pain associated with sunburn

For first aid use to decrease germs in minor cuts and scrapes

WARNINGS

Warnings

For external use only.

Do not use in or near the eyes.

In case of deep or puncture wounds, consult your doctor.

STORAGE AND HANDLING

Flammable, keep away from fire or flame

WARNINGS AND PRECAUTIONS

Avoid contact with the eyes.

If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a doctor.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

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

DOSAGE & ADMINISTRATION

Directions

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

Apply to skin directly or with clean gauze, cotton or swab.

Children under 2 years of age: Consult a doctor.

DESCRIPTION

Other information

Do not use if tamper evident seal is broken, missing or destroyed

INACTIVE INGREDIENT

FD C Blue #1, Fragrance, Water

DESCRIPTION

Manufactured for

Perfumeria Lemaitre LLC

Katy, TX 77491
Product of Columbia

PRINCIPAL DISPLAY PANEL

menticol

first aid antiseptic and external analgesic lotion

Net 8.5 fl oz 250 ml

PRINCIPAL DISPLAY PANEL

menticol

first aid antiseptic and external analgesic lotion

Net 11.8 fl oz 350 ml

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

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INGREDIENTS AND APPEARANCE

MENTICOL FIRST AID ANTISEPTIC AND EXTERNAL ANALGESIC LOTION 
menthol , alcohol lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49199-100
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	0.39 mL  in 100 mL
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	70 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49199-100-10	250 mL in 1 BOTTLE
2	NDC: 49199-100-20	350 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333	12/01/2009

Labeler - Perfumeria Lemaitre S.A. (880262928)

Registrant - Perfumeria Lemaitre S.A. (880262928)

Establishment
Name	Address	ID/FEI	Business Operations
Perfumeria Lemaitre S.A.		880262928	manufacture