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NDC 72481-0101-03 LactiGo 12.5 mg/mL Details

LactiGo 12.5 mg/mL

LactiGo is a TOPICAL GEL in the HUMAN OTC DRUG category. It is labeled and distributed by LactiGo, Inc.. The primary component is MENTHOL, UNSPECIFIED FORM.

Product Information

NDC	72481-0101
Product ID	72481-101_c3dd60dd-f281-2d25-e053-2a95a90a260c
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	LactiGo
Proprietary Name Suffix	n/a
Non-Proprietary Name	MENTHOL
Product Type	HUMAN OTC DRUG
Dosage Form	GEL
Route	TOPICAL
Active Ingredient Strength	12.5
Active Ingredient Units	mg/mL
Substance Name	MENTHOL, UNSPECIFIED FORM
Labeler Name	LactiGo, Inc.
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part348
Listing Certified Through	2024-12-31

Package

Package Images

NDC 72481-0101-03 (72481010103)

Pricing Information	N/A
NDC Package Code	72481-101-03
Billing NDC	72481010103
Package	100 mL in 1 BOTTLE, PUMP (72481-101-03)
Marketing Start Date	2019-03-21
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 849c3601-2bc8-0991-e053-2a91aa0a5e7f Details

Active ingredient

Menthol 1.25%

Purpose

Topical analgesic

Use

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.

SPL UNCLASSIFIED SECTION

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

Questions?

1-844-522-8446

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

LACTIGO

menthol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:72481-101
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A)	MENTHOL, UNSPECIFIED FORM	12.5 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
MAGNESIUM SULFATE ANHYDROUS (UNII: ML30MJ2U7I)
DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)
WATER (UNII: 059QF0KO0R)
CARNOSINE (UNII: 8HO6PVN24W)
XANTHAN GUM (UNII: TTV12P4NEE)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
GLYCERIN (UNII: PDC6A3C0OX)

Product Characteristics
Color	white (White to off white)	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:72481-101-03	100 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	03/21/2019

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	03/21/2019

Labeler - LactiGo, Inc. (116992874)

Revised: 6/2021

Document Id: c3dd60dd-f281-2d25-e053-2a95a90a260c

Set id: 849c3601-2bc8-0991-e053-2a91aa0a5e7f

Version: 2

Effective Time: 20210603