Drug Facts

Drug Facts
SPL v2
SPL
SPL Set ID ee8c1a2b-36ef-6fd7-e053-2a95a90a9c01
Route
TOPICAL
Published
Effective Date 2022-11-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lidocaine (4 g)
Inactive Ingredients
Rice Bran Stearic Acid Ethylhexylglycerin Viburnum Opulus Bark Candelilla Wax Alcohol Water Sorbitan Olivate Sheanut Linseed Oil Phytate Sodium Sodium Stearoyl Lactylate Phenoxyethanol Cetearyl Olivate Glyceryl Monostearate Glycyrrhiza Glabra Ylang-ylang Oil Azadirachta Indica Leaf Aloe Vera Flower Turmeric Xanthan Gum Tribasic Calcium Phosphate Tocopherol Avocado Oil Lavender Oil Eggplant Citric Acid Monohydrate Glycerin Hexylene Glycol Jojoba Oil Glycereth-8 Esters Azadirachta Indica Flower Medium-chain Triglycerides Corallina Officinalis Coccinia Grandis Fruit Holy Basil Leaf Caprylyl Glycol Cetostearyl Alcohol Aloe Vera Leaf Cannabidiol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-11-28

Description

Active Ingredients Lidocaine HCL 4 %


Medication Information

Warnings and Precautions

Warnings

For external use only

Indications and Usage

Uses

Temporarily relieves minor pain associated with Muscle strains,sprain and simple backache,insect bites.

Dosage and Administration

Direction

Adults and children over 12 years of age

apply externally to affected area up to 2-3 time a day.

repeat as necessary, but no more than 4 time daily.

children 12 year or younger ask a doctor

Description

Active Ingredients Lidocaine HCL 4 %

Section 50565-1

Keep out of reach of children

If swallowed get medical help or contact a poison control center right away

Section 50566-9

Stop uses

Condition Worsens

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

Redness is present

Irritation develops

Section 50567-7

When using this Product use only as directed

do not bandage tightly or use with a heating pad

Section 50570-1

Do not uses

Do not apply to wounds or damaged skin

Section 51727-6

Inactive Ingredient

Water ((Aqua), Glyceryl stearate, Butyrospermum Parkii Nut Extract, glycerin, Ceteraryl Alcohol, Broad Spectrum Hemp Extract, Cetearyl Olivate, Aloe Barbadensis Leaf Juice, Caprylic/Capric Triglyceride, Sorbitan Olivate, stearic Acid, Candelilla/Jojoba/Rice Bran Polyglyceride-3Esters, Linum Usitatissimum(Linseed) Seed Oil, Sodium Phytate,Xanthan Gum, Hydroxyapatite, Citric Acid,Tocopherol,

Persea Gratissima (Avocado) Oil,Sodium Stearoyl Lactylate,Viburnum Opulus Bark Extract, Alcohol,Glycyrrhiza Glabra (Licorice) Root Extract, Lavandula Angustifolia (Lavender)Oil,Cananga Odorata Flower Oil, Melia Azadirachta Flower Extract,Corallina Officinalis Extract,Cocconia Indica Fruit Extract,Melia Azadirachta Leaf extract,Solanum Melongena (Eggplant) Fruit Extract, Aloe Barbadensis Flower Extract,Ocimum Sanctum Leaf Extract,Curcuma Longa (Turmeric) Root Extract, Phenoxyethanol,Caprylyl Glycol,Ethylhexylglycerin, Hexylene Glycol

Section 51945-4

Section 55105-1

Purpose

Pain Reliver

Section 55106-9

Active Ingredients

Lidocaine HCL 4 %

Section 60561-8

Other safety information and warning

Warning: For adults only. Consult your physician before use if you are pregnant, lactating, taking medications, or have a medical condition. Keep out of reach of children.

Warning: Consuming this product can expose you to chemicals including lead, which is known to the State of California to cause birth defects or other reproductive harm. For more information go to www.p65warnings.ca.gov.

These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.


Structured Label Content

Indications and Usage (34067-9)

Uses

Temporarily relieves minor pain associated with Muscle strains,sprain and simple backache,insect bites.

Dosage and Administration (34068-7)

Direction

Adults and children over 12 years of age

apply externally to affected area up to 2-3 time a day.

repeat as necessary, but no more than 4 time daily.

children 12 year or younger ask a doctor

Warnings and Precautions (34071-1)

Warnings

For external use only

Section 50565-1 (50565-1)

Keep out of reach of children

If swallowed get medical help or contact a poison control center right away

Section 50566-9 (50566-9)

Stop uses

Condition Worsens

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

Redness is present

Irritation develops

Section 50567-7 (50567-7)

When using this Product use only as directed

do not bandage tightly or use with a heating pad

Section 50570-1 (50570-1)

Do not uses

Do not apply to wounds or damaged skin

Section 51727-6 (51727-6)

Inactive Ingredient

Water ((Aqua), Glyceryl stearate, Butyrospermum Parkii Nut Extract, glycerin, Ceteraryl Alcohol, Broad Spectrum Hemp Extract, Cetearyl Olivate, Aloe Barbadensis Leaf Juice, Caprylic/Capric Triglyceride, Sorbitan Olivate, stearic Acid, Candelilla/Jojoba/Rice Bran Polyglyceride-3Esters, Linum Usitatissimum(Linseed) Seed Oil, Sodium Phytate,Xanthan Gum, Hydroxyapatite, Citric Acid,Tocopherol,

Persea Gratissima (Avocado) Oil,Sodium Stearoyl Lactylate,Viburnum Opulus Bark Extract, Alcohol,Glycyrrhiza Glabra (Licorice) Root Extract, Lavandula Angustifolia (Lavender)Oil,Cananga Odorata Flower Oil, Melia Azadirachta Flower Extract,Corallina Officinalis Extract,Cocconia Indica Fruit Extract,Melia Azadirachta Leaf extract,Solanum Melongena (Eggplant) Fruit Extract, Aloe Barbadensis Flower Extract,Ocimum Sanctum Leaf Extract,Curcuma Longa (Turmeric) Root Extract, Phenoxyethanol,Caprylyl Glycol,Ethylhexylglycerin, Hexylene Glycol

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Purpose

Pain Reliver

Section 55106-9 (55106-9)

Active Ingredients

Lidocaine HCL 4 %

Section 60561-8 (60561-8)

Other safety information and warning

Warning: For adults only. Consult your physician before use if you are pregnant, lactating, taking medications, or have a medical condition. Keep out of reach of children.

Warning: Consuming this product can expose you to chemicals including lead, which is known to the State of California to cause birth defects or other reproductive harm. For more information go to www.p65warnings.ca.gov.

These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.


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Raw Label Data

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