LIDOTHAL RELIEF- menthol, lidocaine patch

Lidothal Relief by

Drug Labeling and Warnings

Lidothal Relief by is a Otc medication manufactured, distributed, or labeled by 19 And Pacific, Llc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient

Menthol  1.00%

Lidocaine 4.00%

PURPOSE

Purpose

External analgesic

External analgesic

INDICATIONS & USAGE

Uses:

For temporary relief of minor aches and pains of the muscles and joints associated with simple backache, arthritis, strains,

bruises and sprains

WARNINGS

Warnings:

• For external use only
• Avoid contact with eyes
• Do not apply to open wounds or damages skin
• If symptoms persist for more than seven days, discontinue use and consult physician
• Keep out of reach of children. If swallowed, consult physician.
• Do not bandage tightly
• If pregnant or breast feeding, contact physician prior to use

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed, consult physician.

DOSAGE & ADMINISTRATION

Directions:

• Clean and dry affected area
• Remove patch from backing and apply to affected area. Apply directly to affected area.
• Use only on patch at a time, and a maximum of four patches per day.
• Leave patch of affected area for up to eight hours.
• Do not use patches for more than five consecutive days
• Children under 12 should consult a physician prior to use.

STORAGE AND HANDLING

Store at room temperature. Avoid direct sunlight.

INACTIVE INGREDIENT

Other Ingredients:

acrylic acid ,aluminum hydroxide . carmellose sodium 2-ethylexyl acrylate glycerin . isopropyl myristate .methyl acrylate

nonoxynol-30 .poluacrylate.polyacrylic acid .polysorbate 80 sorbitan sesquioleate strach .talc .tartaric acid

.titanium dioxide .water(254-114)

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

LIDOTHAL RELIEF 
menthol, lidocaine patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71437-463
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	1 g  in 100 g
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	4 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
ACRYLIC ACID (UNII: J94PBK7X8S)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
2-ETHYLHEXYL ACRYLATE (UNII: HR49R9S6XG)
GLYCERIN (UNII: PDC6A3C0OX)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
METHYL ACRYLATE (UNII: WC487PR91H)
NONOXYNOL-30 (UNII: JJX07DG188)
POLYACRYLAMIDE (10000 MW) (UNII: E2KR9C9V2I)
POLYACRYLIC ACID (250000 MW) (UNII: 9G2MAD7J6W)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
TALC (UNII: 7SEV7J4R1U)
TARTARIC ACID (UNII: W4888I119H)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71437-463-15	15 in 1 BOX	07/31/2017
1		8.5 g in 1 PATCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	07/31/2017

Labeler - 19 And Pacific, Llc (080619263)

Establishment
Name	Address	ID/FEI	Business Operations
19 And Pacific, Llc		080619263	label(71437-463) , pack(71437-463)