Pain Relieving Lidocaine 4% Dry Spray

Pain Relieving Lidocaine 4% Dry Spray
SPL v4
SPL
SPL Set ID ce2b9e57-749d-715c-e053-2995a90aaf8d
Route
TOPICAL
Published
Effective Date 2022-07-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lidocaine (4 g)
Inactive Ingredients
Isobutane Medium-chain Triglycerides Propylene Glycol Dehydrated Alcohol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-08-02

Description

Lidocaine 4%


Medication Information

Warnings and Precautions

For External use only

Indications and Usage

temporarily relieves minor joint and muscle pain

Dosage and Administration

adults and children over 12 years :

spray affected area every 6 to 8 hours, not to exceed 3 applications in a 24 hour period

product wil dry quickly on its own, and does not need to be rubbed in

children 12 years or younger: ask a doctor

Description

Lidocaine 4%

Section 50565-1

Keep out of reach of children

if swallowed, get medical help or contact Poison Control Center Right Away

Section 50566-9

Stop use and ask a doctor if

condition worsens

redness is present

irritation develops

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

Section 50567-7

When using this product

use only as directed. Read and follow all directions and warnings on this label.

do not allow contact with the eyes and mucous membranes

avoid spraying on face

avoid inhalation of spray

do not bandage or apply local heat (such as heating pads) or a medicated patch to area of use

do not use at the same time as other topical analgesics

Section 50570-1

Do not use

on large areas of the body or on cut, irritated or swollen skin

on puncture wounds

for more than one week without consulting a doctor

Extremely Flammable

do not use near heat or flame or while smoking

avoid long term storage above 104° F (40°C)

do not puncture or incinerate. Contents under pressure.

do not store at temperatures above 120F (49°C)

Section 51727-6

caprylic/capric triglyceride, isobutane, propylene glycol, SD alcohol 40 B (30%)

Section 51945-4

Section 53413-1

1-800-925-4733

Section 53414-9

If pregnant or breast-feeding, ask a health professional before use

Section 55105-1

Topical anesthetic

Section 55106-9

Lidocaine 4%


Structured Label Content

Indications and Usage (34067-9)

temporarily relieves minor joint and muscle pain

Dosage and Administration (34068-7)

adults and children over 12 years :

spray affected area every 6 to 8 hours, not to exceed 3 applications in a 24 hour period

product wil dry quickly on its own, and does not need to be rubbed in

children 12 years or younger: ask a doctor

Warnings and Precautions (34071-1)

For External use only

Section 50565-1 (50565-1)

Keep out of reach of children

if swallowed, get medical help or contact Poison Control Center Right Away

Section 50566-9 (50566-9)

Stop use and ask a doctor if

condition worsens

redness is present

irritation develops

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

Section 50567-7 (50567-7)

When using this product

use only as directed. Read and follow all directions and warnings on this label.

do not allow contact with the eyes and mucous membranes

avoid spraying on face

avoid inhalation of spray

do not bandage or apply local heat (such as heating pads) or a medicated patch to area of use

do not use at the same time as other topical analgesics

Section 50570-1 (50570-1)

Do not use

on large areas of the body or on cut, irritated or swollen skin

on puncture wounds

for more than one week without consulting a doctor

Extremely Flammable

do not use near heat or flame or while smoking

avoid long term storage above 104° F (40°C)

do not puncture or incinerate. Contents under pressure.

do not store at temperatures above 120F (49°C)

Section 51727-6 (51727-6)

caprylic/capric triglyceride, isobutane, propylene glycol, SD alcohol 40 B (30%)

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

1-800-925-4733

Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health professional before use

Section 55105-1 (55105-1)

Topical anesthetic

Section 55106-9 (55106-9)

Lidocaine 4%


Advanced Ingredient Data


Raw Label Data

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