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NDC 69842-0615-01 CVS Pain Relieving First Aid Antiseptic .0013; .025 g/g; g/g Details

CVS Pain Relieving First Aid Antiseptic .0013; .025 g/g; g/g

CVS Pain Relieving First Aid Antiseptic is a TOPICAL SPRAY in the HUMAN OTC DRUG category. It is labeled and distributed by CVS Pharmacy. The primary component is BENZALKONIUM CHLORIDE; LIDOCAINE HYDROCHLORIDE.

Product Information

NDC	69842-0615
Product ID	69842-615_45d91c02-243a-6ebe-e054-00144ff88e88
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	CVS Pain Relieving First Aid Antiseptic
Proprietary Name Suffix	n/a
Non-Proprietary Name	Lidocaine Hydrochloride, Benzalkonium Chloride
Product Type	HUMAN OTC DRUG
Dosage Form	SPRAY
Route	TOPICAL
Active Ingredient Strength	.0013; .025
Active Ingredient Units	g/g; g/g
Substance Name	BENZALKONIUM CHLORIDE; LIDOCAINE HYDROCHLORIDE
Labeler Name	CVS Pharmacy
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 69842-0615-01 (69842061501)

Pricing Information	N/A
NDC Package Code	69842-615-01
Billing NDC	69842061501
Package	147.85 g in 1 BOTTLE, SPRAY (69842-615-01)
Marketing Start Date	2014-05-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 454b1773-eda8-5610-e054-00144ff88e88 Details

Drug Facts

Active Ingredients

Benzalkonium Cl 0.13% w/w

Lidocaine HCl 2.5% w/w

Purpose

First aid antiseptic

Pain reliever

Uses

Firs aid to help prevent bacterial contamination or skin infections, and temporary relief of pain and itching associated with minor:

cuts

scrapes

burns

sunburns

skin irritations

Warnings

For external use only

Ask doctor before use if you have

deep or puncture wounds

animal bites

serious burns

When using this product

do not use near the eyes

do not apply over large areas of the body or in large quantities

do not apply over raw surfaces or blistered areas

Stop use and ask a doctor if

condition worsens

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

Keep out of reach of children.

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

Directions

Adults and children 2 years and older:

clean the affected area

apply a small amount on the area 1 to 3 times daily.

may be covered with a sterile bandage

if bandaged, let dry first.

Other Information

Protect from excessive heat.

Questions or comments

1-800-635-3696

Inactive Ingredients

Camphor, Deionized Water, Propylene Glycol

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CVS PAIN RELIEVING FIRST AID ANTISEPTIC

lidocaine hydrochloride, benzalkonium chloride spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:69842-615
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE HYDROCHLORIDE	0.025 g in 1 g
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.0013 g in 1 g

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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:69842-615-01	147.85 g in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	05/01/2014

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	04/15/2014

Labeler - CVS Pharmacy (062312574)

Revised: 1/2017

Document Id: 45d91c02-243a-6ebe-e054-00144ff88e88

Set id: 454b1773-eda8-5610-e054-00144ff88e88

Version: 2

Effective Time: 20170104