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NDC 69842-0710-01 CVSLidocaineAntisepticSpray .013; .04 g/g; g/g Details

CVSLidocaineAntisepticSpray .013; .04 g/g; g/g

CVSLidocaineAntisepticSpray is a TOPICAL SPRAY in the HUMAN OTC DRUG category. It is labeled and distributed by CVS Health. The primary component is BENZALKONIUM CHLORIDE; LIDOCAINE.

Product Information

NDC	69842-0710
Product ID	69842-710_d57c1b4e-89af-4029-e053-2995a90a1b0e
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	CVSLidocaineAntisepticSpray
Proprietary Name Suffix	n/a
Non-Proprietary Name	LIDOCAINE and BENZALKONIUM CHLORIDE
Product Type	HUMAN OTC DRUG
Dosage Form	SPRAY
Route	TOPICAL
Active Ingredient Strength	.013; .04
Active Ingredient Units	g/g; g/g
Substance Name	BENZALKONIUM CHLORIDE; LIDOCAINE
Labeler Name	CVS Health
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	2023-12-31

Package

Package Images

NDC 69842-0710-01 (69842071001)

Pricing Information	N/A
NDC Package Code	69842-710-01
Billing NDC	69842071001
Package	113 g in 1 CAN (69842-710-01)
Marketing Start Date	2020-04-17
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL a35ab6f7-07e3-adef-e053-2a95a90a4d5d Details

SPL UNCLASSIFIED SECTION

Temporarily relieves pain and itching due to: sunburn,minor burns,minor cuts,scrapes, insect bites,minor skin irritations,First aid to help kill germs.

Drug Facts

Active ingredients

Active ingredients	Purposes
Benzalkonium Chloride 0.13% (w/w)	First Aid Antiseptic
Lidocaine HCl 4.0% (w/w)	External Analgesic

Uses

■ Temporarily relieves pain and itching due to: ■ sunburn ■ minor burns ■ minor cuts

■ scrapes ■ insect bites ■ minor skin irritations ■ First aid to help kill germs

Warnings

For external use only.

Do not use in large quantities, particularly over raw surfaces or blistered areas

When using this product ■ keep out of eyes ■ use only as directed

Stop use and ask doctor if ■ condition gets worse ■ symptoms last more than 7 days

■ symptoms clear up and occur again in a few days

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control

Center immediately.

Directions

■ adults and children 2 years of age and older apply to affected area not more than 3 to 4 times daily ■ children under 2 years of age: ask a doctor ■ to apply to face, spray into palm of hand and gently apply

Other information

Keep cap tightly closed when not in use. Contents under pressure. Do not puncture or incinerate. Store at temperatures between 45ºF-130ºF (7º-54ºC). Avoid excessive heat.

Inactive ingredients

Camphor, Deionized Water, Propylene Glycol, Sodium Hydroxide

Questions or comments?

1-800-635-3696

Principal Display Panel

CVS

Health ™

MAXIMUM STRENGTH

Lidocaine

Antiseptic

Spray

BENZALKONIUM Cl 0.13%

LIDOCAINE HCl 4%

First aid antiseptic

Pain reliever

SPRAYS

ANY ANGLE

Soothing infection

protection

Relieves pain

on contact

Kills germs

NET WT 4 OZ (113 g)

INGREDIENTS AND APPEARANCE

CVSLIDOCAINEANTISEPTICSPRAY

lidocaine and benzalkonium chloride spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:69842-710
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.013 g in 1 g
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	0.04 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)
WATER (UNII: 059QF0KO0R)
SODIUM HYDROXIDE (UNII: 55X04QC32I)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:69842-710-01	113 g in 1 CAN; Type 0: Not a Combination Product	04/17/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	04/17/2020

Labeler - CVS Health (062312574)

Revised: 1/2022

Document Id: d57c1b4e-89af-4029-e053-2995a90a1b0e

Set id: a35ab6f7-07e3-adef-e053-2a95a90a4d5d

Version: 3

Effective Time: 20220113