Wkv Lidohcl

Wkv Lidohcl
SPL v6
SPL
SPL Set ID aebaffb5-58dd-ebd5-e053-2a95a90a14ed
Route
TOPICAL
Published
Effective Date 2020-10-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (1 g)
Inactive Ingredients
Glycerin Glycol Stearate Horse Chestnut Isopropyl Myristate Peg-100 Stearate Arnica Montana Caprylyl Glycol Chamomile Rosemary Oil Aloe Vera Leaf Lemon Balm Oil Linden Leaf Dimethyl Sulfone Phenoxyethanol Salix Nigra Bark Eucalyptus Globulus Leaf Glucosamine Sulfate Potassium Chloride Glyceryl Monostearate Menthyl Lactate, (-)- Almond Oil Harpagophytum Procumbens Root C13-14 Isoparaffin Fruit Bromelain Dimethicone Capsicum Annuum Whole Polyacrylamide (10000 Mw) Laureth-7

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-09-28

Description

Active Ingredients Lidocaine HCL 4% w/w Menthol 1% w/w


Medication Information

Warnings and Precautions

Warnings

For external use only. Avoid contact with eyes.

Indications and Usage

USES For temporary relief of pain.

Dosage and Administration

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.

Description

Active Ingredients Lidocaine HCL 4% w/w Menthol 1% w/w

Section 50565-1

Keep out of reach of children, if swallowed, get medical help or contact a Poison Control Center right away.

If pregnant or breast feeding, ask a health professional.

Section 50569-3

Stop use and ask a doctor if condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days.

Section 50570-1

Do not use in large quantities, particularly over raw surfaces, or blistered areas.

Section 51727-6

Inactive Ingredients

Aloe Barbadensis Leaf Extract, Arnica Extract, Bromelain, C13-14 Isoparaffin, Caprylyl Glycol, Capsicum Annuum Fruit Extract, Chamomile Extract, Devil’s Claw Extract, Dimethicone, Dimethyl Sulfone (MSM), Eucalyptus Oil, Glucosamine Sulfate, Glycerin, Glyceryl Stearate, Glycol Stearate, Horse Chestnut Extract, Isopropyl Myristate, Laureth-7, Lemon Balm Extract, Linden Flower Extract, Menthyl Lactate, PEG-100 Stearate, Phenoxyethanol, Polyacrylamide, Rosemary Extract, Sweet Almond Oil, Water, Willow Bark Extract

Section 51945-4

Section 53413-1

Questions or comments

[email protected]

Section 55105-1

Purpose

Topical analgesic

Topical analgesic

Section 55106-9

Active Ingredients

Lidocaine HCL 4% w/w

Menthol 1% w/w

Section 60561-8

Other Information

store in a cool dry place between (59-86°F) 15-30°C

don't use if seal over cap is broken, torn or missing


Structured Label Content

Indications and Usage (34067-9)

USES For temporary relief of pain.

Dosage and Administration (34068-7)

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.

Warnings and Precautions (34071-1)

Warnings

For external use only. Avoid contact with eyes.

Section 50565-1 (50565-1)

Keep out of reach of children, if swallowed, get medical help or contact a Poison Control Center right away.

If pregnant or breast feeding, ask a health professional.

Section 50569-3 (50569-3)

Stop use and ask a doctor if condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days.

Section 50570-1 (50570-1)

Do not use in large quantities, particularly over raw surfaces, or blistered areas.

Section 51727-6 (51727-6)

Inactive Ingredients

Aloe Barbadensis Leaf Extract, Arnica Extract, Bromelain, C13-14 Isoparaffin, Caprylyl Glycol, Capsicum Annuum Fruit Extract, Chamomile Extract, Devil’s Claw Extract, Dimethicone, Dimethyl Sulfone (MSM), Eucalyptus Oil, Glucosamine Sulfate, Glycerin, Glyceryl Stearate, Glycol Stearate, Horse Chestnut Extract, Isopropyl Myristate, Laureth-7, Lemon Balm Extract, Linden Flower Extract, Menthyl Lactate, PEG-100 Stearate, Phenoxyethanol, Polyacrylamide, Rosemary Extract, Sweet Almond Oil, Water, Willow Bark Extract

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Questions or comments

[email protected]

Section 55105-1 (55105-1)

Purpose

Topical analgesic

Topical analgesic

Section 55106-9 (55106-9)

Active Ingredients

Lidocaine HCL 4% w/w

Menthol 1% w/w

Section 60561-8 (60561-8)

Other Information

store in a cool dry place between (59-86°F) 15-30°C

don't use if seal over cap is broken, torn or missing


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)