Drug Facts

Drug Facts
SPL v2
SPL
SPL Set ID bdbd4106-e4fe-4daf-a757-3aee3a87bb09
Route
TOPICAL
Published
Effective Date 2017-09-03
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lidocaine (4 g)
Inactive Ingredients
Dihydroxyaluminum Aminoacetate Glycerin Kaolin Methylparaben Propylparaben Propylene Glycol Povidone, Unspecified Polyacrylic Acid (8000 Mw) Polysorbate 80 Sodium Polyacrylate (8000 Mw) Titanium Dioxide Tartaric Acid Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2017-08-20

Description

Active ingredients Lidocaine 4%


Medication Information

Warnings and Precautions

Warnings  for external use only.

Do not use

•more than one patch on your body at a time or on cut  •on wounds or damaged skin  •with a heating pad

When using this product

•avoid contact with eyes, mucous membranes or rashes  •use only as directed  •do not bandage tightly

•do not use at the same time as other topical analgesics  •dispose of used patch in a manner that always keeps products away from children and pets

Stop  use and ask a doctor if

•you experience signs of skin injury, such as pain, swelling or blistering where product was applied •symptoms persist for more than 7

days or clear up and occur again within a few days  •condition worsens  •redness is present  •irritation develops

Indications and Usage

Uses  temporarily releives minor pain

Dosage and Administration

Directions  Adults and children 12 years of age and over:

•Clean and dry affected area  •Remove film from patch and apply to the skin (see package for instructions)

•Apply to affected area not more than 3 to 4 times daily  •Remove patch from the skin after at most 8 hours of application

Children under 12 years of age: consult a physician

Description

Active ingredients Lidocaine 4%

Section 44425-7

Other information

•Store at room temperature 58° - 86° F (15° - 30° C). Acoid storing product in direct sunlight  •Protect product from excessive moisture

Section 50565-1

Keep out of reach of children. On case of accidental ingestion, get medical help or contact a Poison Control Center right away.

Section 51727-6

Inactive ingredients DIHYDROXYALUMINUM AMINOACETATE, GLYCERIN, KAOLIN, METHYLPARABEN, PROPYLPARABEN, PROPYLENE GLYCOL,

PVP, POLYACRYLIC ACID, POLYSORBATE 80, SODIUM POLYACRYLATE, TITANIUM DIOXIDE, TARTARIC ACID, WATER

Section 51945-4

Section 53414-9

Pregnancy.breast-feeding warning. If pregant or breast-feeding, ask a health professional before use.

Section 55105-1

Purpose

Topical analgesic

Section 55106-9

Active ingredients

Lidocaine 4%


Structured Label Content

Indications and Usage (34067-9)

Uses  temporarily releives minor pain

Dosage and Administration (34068-7)

Directions  Adults and children 12 years of age and over:

•Clean and dry affected area  •Remove film from patch and apply to the skin (see package for instructions)

•Apply to affected area not more than 3 to 4 times daily  •Remove patch from the skin after at most 8 hours of application

Children under 12 years of age: consult a physician

Warnings and Precautions (34071-1)

Warnings  for external use only.

Do not use

•more than one patch on your body at a time or on cut  •on wounds or damaged skin  •with a heating pad

When using this product

•avoid contact with eyes, mucous membranes or rashes  •use only as directed  •do not bandage tightly

•do not use at the same time as other topical analgesics  •dispose of used patch in a manner that always keeps products away from children and pets

Stop  use and ask a doctor if

•you experience signs of skin injury, such as pain, swelling or blistering where product was applied •symptoms persist for more than 7

days or clear up and occur again within a few days  •condition worsens  •redness is present  •irritation develops

Section 44425-7 (44425-7)

Other information

•Store at room temperature 58° - 86° F (15° - 30° C). Acoid storing product in direct sunlight  •Protect product from excessive moisture

Section 50565-1 (50565-1)

Keep out of reach of children. On case of accidental ingestion, get medical help or contact a Poison Control Center right away.

Section 51727-6 (51727-6)

Inactive ingredients DIHYDROXYALUMINUM AMINOACETATE, GLYCERIN, KAOLIN, METHYLPARABEN, PROPYLPARABEN, PROPYLENE GLYCOL,

PVP, POLYACRYLIC ACID, POLYSORBATE 80, SODIUM POLYACRYLATE, TITANIUM DIOXIDE, TARTARIC ACID, WATER

Section 51945-4 (51945-4)

Section 53414-9 (53414-9)

Pregnancy.breast-feeding warning. If pregant or breast-feeding, ask a health professional before use.

Section 55105-1 (55105-1)

Purpose

Topical analgesic

Section 55106-9 (55106-9)

Active ingredients

Lidocaine 4%


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)