Search by Drug Name or NDC

NDC 69842-0543-04 Lidocaine Dry 4 g/100mL Details

Lidocaine Dry 4 g/100mL

Lidocaine Dry is a TOPICAL SPRAY in the HUMAN OTC DRUG category. It is labeled and distributed by CVS. The primary component is LIDOCAINE.

Product Information

NDC	69842-0543
Product ID	69842-543_c8a81a2c-d73f-0b0a-e053-2a95a90ace9d
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Lidocaine Dry
Proprietary Name Suffix	n/a
Non-Proprietary Name	lidocaine
Product Type	HUMAN OTC DRUG
Dosage Form	SPRAY
Route	TOPICAL
Active Ingredient Strength	4
Active Ingredient Units	g/100mL
Substance Name	LIDOCAINE
Labeler Name	CVS
Pharmaceutical Class	Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part348
Listing Certified Through	2024-12-31

Package

Package Images

NDC 69842-0543-04 (69842054304)

Pricing Information	N/A
NDC Package Code	69842-543-04
Billing NDC	69842054304
Package	113 mL in 1 CAN (69842-543-04)
Marketing Start Date	2021-07-22
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL bb7955fe-5113-1662-e053-2a95a90a85a1 Details

Active Ingredient

Lidocaine 4%

Topical Anesthetic

Use

temporarily relieves minor pain

Warnings

For external use only

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

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 heatl(such as heating pads) or a medicated patch to area of use
do not use at the same time as other topical analgesics

Stop use and as a doctor if

condition worsens
redness is present
irritation develops
symptoms perisist for more than 7 days or clear up and occur again within a few days.

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 120°F (49°C)

If pregnant or breast-feeding

ask a health professional before use.

Keep out of reach of children

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

Directions

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

children 12 years or younger: ask a doctor

Inactive Ingredients

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

Principal Display Panel

INGREDIENTS AND APPEARANCE

LIDOCAINE DRY

lidocaine spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:69842-543
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	4 g in 100 mL

Ingredient Name	Strength
Inactive Ingredients
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
ALCOHOL (UNII: 3K9958V90M)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:69842-543-04	113 mL in 1 CAN; Type 0: Not a Combination Product	07/22/2021

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	07/22/2021

Labeler - CVS (062312574)

Revised: 8/2021

Document Id: c8a81a2c-d73f-0b0a-e053-2a95a90ace9d

Set id: bb7955fe-5113-1662-e053-2a95a90a85a1

Version: 3

Effective Time: 20210804