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NDC 46122-0656-25 First Aid .13; 2.5 g/100mL; g/100mL Details

First Aid .13; 2.5 g/100mL; g/100mL

First Aid is a TOPICAL LIQUID in the HUMAN OTC DRUG category. It is labeled and distributed by Amerisource Bergen. The primary component is BENZALKONIUM CHLORIDE; LIDOCAINE HYDROCHLORIDE.

Product Information

NDC	46122-0656
Product ID	46122-656_d5ca4314-4c4a-65f5-e053-2995a90a91f1
Associated GPIs	90859902850918
GCN Sequence Number	061747
GCN Sequence Number Description	lidocaine HCl/benzalkonium chl SPRAY 2.5%-0.13% TOPICAL
HIC3	Q5H
HIC3 Description	TOPICAL LOCAL ANESTHETICS
GCN	97533
HICL Sequence Number	010610
HICL Sequence Number Description	LIDOCAINE HCL/BENZALKONIUM CHLORIDE
Brand/Generic	Generic
Proprietary Name	First Aid
Proprietary Name Suffix	GNP
Non-Proprietary Name	Benzalkonium Cl 0.13% Lidocaine Hl 2.5%
Product Type	HUMAN OTC DRUG
Dosage Form	LIQUID
Route	TOPICAL
Active Ingredient Strength	.13; 2.5
Active Ingredient Units	g/100mL; g/100mL
Substance Name	BENZALKONIUM CHLORIDE; LIDOCAINE HYDROCHLORIDE
Labeler Name	Amerisource Bergen
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	part333A
Listing Certified Through	2023-12-31

Package

Package Images

NDC 46122-0656-25 (46122065625)

Pricing Information
NDC Package Code	46122-656-25
Billing NDC	46122065625
Package	148 mL in 1 CONTAINER (46122-656-25)
Marketing Start Date	2021-01-14
NDC Exclude Flag	N
Price Per Unit	0.02384
Pricing Unit	ML
Effective Date	2022-11-23
NDC Description	GNP FIRST AID ANTISEPTIC SPRAY
Pharmacy Type Indicator	C/I
OTC	Y
Explanation Code	1, 5
Classification for Rate Setting	G
As of Date	2022-11-23

This pricing file, entitled the NADAC (National Average Drug Acquisition Cost) files, provide state Medicaid agencies with covered outpatient drug prices by averaging survey invoice prices from retail community pharmacies across the United States. These pharmacies include independent retail community pharmacies and chain pharmacies. The prices are updated on a weekly and monthly basis

Standard Product Labeling (SPL)/Prescribing Information SPL 199d93f2-2e29-4087-b18e-26bbc4a693ae Details

Active ingredients Purpose

Benzalkomium Cl 0.13% ..................... Arst Aid Arrliseplc

Lidocaine Hydrochlonde 2.5% ............ Pain Relieving Spray

SPL UNCLASSIFIED SECTION

Uses

First aid to help prevent bacterial contamination or skin infection, and for temporary relief of pain and itching associated with minor:

cuts, scrapes, burns, sunburns, skin irritations

Warnings For external use only

Ask a doctor before use if you have: deep or puncture wounds, animal bites, serious burns

When using this product • do not use in or near the eyes

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

• do not apply over raw surtaces 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 Contrnl Center right away.

Directions

• Adults and children 2 years and older: clean the affected area.

Apply small amount on the area 1 ·3 times daily; May be covered with sterile bandage (let dry first)

Children under 2 years: ask a doctor

Other information

Avoid excessive heat

Inactive ingredients

Diazolidinyl Urea, Disodium Edta, Fragrance, Methylparaben, Nonoxynol-9, Propylene Glycol, Propylparaben, Sodium Phosphate DIbasic, Water.

Questions?

888-793-8450

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

FIRST AID GNP

benzalkonium cl 0.13% lidocaine hl 2.5% liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:46122-656
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.13 g in 100 mL
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	2.5 g in 100 mL

Ingredient Name	Strength
Inactive Ingredients
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
EDETATE DISODIUM (UNII: 7FLD91C86K)
METHYLPARABEN (UNII: A2I8C7HI9T)
NONOXYNOL-9 (UNII: 48Q180SH9T)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
SODIUM PHOSPHATE DIBASIC DIHYDRATE (UNII: 94255I6E2T)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:46122-656-25	148 mL in 1 CONTAINER; Type 0: Not a Combination Product	01/14/2021

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	01/14/2021

Labeler - Amerisource Bergen (007914906)

Registrant - Inspec Solutions LLC (081030372)

Name	Address	ID/FEI	Business Operations
Establishment
Inspec Solutions LLC		081030372	manufacture(46122-656)

Revised: 1/2022

Document Id: d5ca4314-4c4a-65f5-e053-2995a90a91f1

Set id: 199d93f2-2e29-4087-b18e-26bbc4a693ae

Version: 3

Effective Time: 20220117