LACTIGO- menthol gel

United States - English - NLM (National Library of Medicine)

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Active ingredient:
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A)
Available from:
LactiGo, Inc.
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
Topical analgesic For the temporary relief of minor aches and pains of muscles and joints.
Authorization status:
OTC monograph not final
Authorization number:
72481-101-03

LACTIGO- menthol gel

LactiGo, Inc.

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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LactiGo with Menthol Performance & Recovery Gel

Active ingredient

Menthol 1.25%

Purpos e

Topical analgesic

Us e

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

Warnings

For external use only.

Avoid contact with eyes and mucous membranes.

If contention 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.

Do not apply to wounds or damaged skin.

Do not bandage tightly.

Keep out of reach of children to avoid accidental ingestion.

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

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 at 15°C to 30°C (59°F to 86°F).

Inactive ingredients

Ethoxydiglycol, glycerine, L-carnosine, magnesium sulfate, phenoxyethanol, water, xanthan gum

Ques tions ?

1-844-522-8446

LACTIGO

menthol gel

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:7248 1-10 1

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

MENTHO L, UNSPECIFIED FO RM (UNII: L7T10 EIP3A) (MENTHOL, UNSPECIFIED FORM -

UNII:L7T10 EIP3A)

MENTHOL, UNSPECIFIED

FORM

12.5 mg

in 1 mL

Inactive Ingredients

Ingredient Name

Stre ng th

CARNO SINE (UNII: 8 HO6 PVN24W)

XANTHAN GUM (UNII: TTV12P4NEE)

GLYCERIN (UNII: PDC6 A3C0 OX)

PHENO XYETHANO L (UNII: HIE49 2ZZ3T)

MAGNESIUM SULFATE ANHYDRO US (UNII: ML30 MJ2U7I)

DIETHYLENE GLYCO L MO NO ETHYL ETHER (UNII: A1A1I8 X0 2B)

WATER (UNII: 0 59 QF0 KO0 R)

Product Characteristics

Color

white (White to o ff white)

S core

S hap e

S iz e

Flavor

Imprint Code

Contains

LactiGo, Inc.

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End

Date

1

NDC:7248 1-10 1-

10 0 mL in 1 BOTTLE, PUMP; Type 0 : No t a Co mbinatio n

Pro duc t

0 3/21/20 19

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph no t final

pa rt348

0 3/21/20 19

Labeler -

LactiGo, Inc. (116992874)

Revised: 3/2019

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