83037-041-02

83037-041-02
SPL v1
SPL
SPL Set ID 063387e4-a1b1-a467-e063-6294a90a6cbd
Route
TOPICAL
Published
Effective Date 2023-10-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (1 g)
Inactive Ingredients
Almond Oil Dimethyl Sulfone Isopropyl Myristate Methylpropanediol Arnica Montana Flower .alpha.-tocopherol Acetate Water Peg-100 Stearate Stearyl Alcohol Glycol Stearate Sodium Lauryl Sulfate Glycerin Dimethicone 1000 Caprylhydroxamic Acid Caprylyl Glycol Phenoxyethanol Aloe Vera Leaf Glyceryl Stearate Se Eucalyptus Globulus Leaf Rosemary Oil Chamomile Salix Alba Bark Capsicum Annuum Whole Xanthan Gum Polysorbate 20 Glucosamine Sulfate

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-10-17

Description

Lidocaine HCl 4% Menthol 1%


Medication Information

Warnings and Precautions

For external use only.

Ask a doctor before use if you have redness over affected area.

Description

Lidocaine HCl 4% Menthol 1%

Uses:

For temporary local relief of minor pain in muscles or joints.

Section 50565-1

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

Section 50567-7

Use only as directed.

Avoid contact with eyes and mucous membranes.

Do not bandage tightly or use with a heating pad.

A transient burning sensation or redness may occur upon application but generally disappears in several days.

Do not apply on large areas of the body or on damaged, broken, or irritated skin.

Section 51727-6

Water, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Isopropyl Myristate, Glycol Stearate, Stearyl Alcohol, Glyceryl Stearate, PEG-100 Stearate, Sodium Lauryl Sulfate, Dimethicone, Glycerin, Caprylhydroxamic Acid, Caprylyl Glycol, Eucalyptus Globulus Leaf Oil, Phenoxyethanol, Methylpropanediol, Acrylamide/Sodium Acrylate Copolymer, Paraffinum Liquidum, Trideceth-6, Methylsulfonylmethane, Aloe Barbadensis (Aloe Vera) Leaf Juice, Rosmarinus Officinalis (Rosemary) Oil, Tocopheryl Acetate, Arnica Montana Flower Extract, Salix Alba Bark Extract, Glucosamine Sulfate, Chamomilla Recutita (Matricaria) Flower Extract, Capsicum Annuum Fruit Extract.

Section 53414-9

Ask a health professional before use.

Section 55105-1

Topical Analgesic

Section 55106-9

Lidocaine HCl 4%

Menthol 1%

Section 60561-8

Store at room temperature 15° - 30°C (59° - 86°F)

Directions:

Adults and children over 12 years of age

Apply a small amount to the affected area.

Massage in a circular motion, let set for a few seconds.

Repeat as necessary, but no more than 3 to 4 times daily.

Children under 12 years of age; do not use unless directed by doctor.

Dzul Lido Creme Roll On

Stop Use and Ask A Doctor If:

Redness is present.

Condition worsens.

Irritation develops.

Symptoms persist for more than 7 days or clear up and occur again within a few days.

You experience signs injury, such as pain, swelling or blistering where the product was applied.


Structured Label Content

Uses: (USES:)

For temporary local relief of minor pain in muscles or joints.

Warnings and Precautions (34071-1)

For external use only.

Ask a doctor before use if you have redness over affected area.

Section 50565-1 (50565-1)

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

Section 50567-7 (50567-7)

Use only as directed.

Avoid contact with eyes and mucous membranes.

Do not bandage tightly or use with a heating pad.

A transient burning sensation or redness may occur upon application but generally disappears in several days.

Do not apply on large areas of the body or on damaged, broken, or irritated skin.

Section 51727-6 (51727-6)

Water, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Isopropyl Myristate, Glycol Stearate, Stearyl Alcohol, Glyceryl Stearate, PEG-100 Stearate, Sodium Lauryl Sulfate, Dimethicone, Glycerin, Caprylhydroxamic Acid, Caprylyl Glycol, Eucalyptus Globulus Leaf Oil, Phenoxyethanol, Methylpropanediol, Acrylamide/Sodium Acrylate Copolymer, Paraffinum Liquidum, Trideceth-6, Methylsulfonylmethane, Aloe Barbadensis (Aloe Vera) Leaf Juice, Rosmarinus Officinalis (Rosemary) Oil, Tocopheryl Acetate, Arnica Montana Flower Extract, Salix Alba Bark Extract, Glucosamine Sulfate, Chamomilla Recutita (Matricaria) Flower Extract, Capsicum Annuum Fruit Extract.

Section 53414-9 (53414-9)

Ask a health professional before use.

Section 55105-1 (55105-1)

Topical Analgesic

Section 55106-9 (55106-9)

Lidocaine HCl 4%

Menthol 1%

Section 60561-8 (60561-8)

Store at room temperature 15° - 30°C (59° - 86°F)

Directions: (DIRECTIONS:)

Adults and children over 12 years of age

Apply a small amount to the affected area.

Massage in a circular motion, let set for a few seconds.

Repeat as necessary, but no more than 3 to 4 times daily.

Children under 12 years of age; do not use unless directed by doctor.

Dzul Lido Creme Roll On (DZUL - LIDO CREME ROLL-ON)

Stop Use and Ask A Doctor If: (STOP USE AND ASK A DOCTOR IF:)

Redness is present.

Condition worsens.

Irritation develops.

Symptoms persist for more than 7 days or clear up and occur again within a few days.

You experience signs injury, such as pain, swelling or blistering where the product was applied.


Advanced Ingredient Data


Raw Label Data

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