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NDC 00924-0009-00 First Aid Only Alcohol Antiseptic Pad 70 g/100g Details

First Aid Only Alcohol Antiseptic Pad 70 g/100g

First Aid Only Alcohol Antiseptic Pad is a TOPICAL SWAB in the HUMAN OTC DRUG category. It is labeled and distributed by Acme United Corporation. The primary component is ISOPROPYL ALCOHOL.

Product Information

NDC	00924-0009
Product ID	0924-0009_801168e9-ebef-fe3a-e053-2991aa0a1eb0
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	First Aid Only Alcohol Antiseptic Pad
Proprietary Name Suffix	n/a
Non-Proprietary Name	Alcohol Pad
Product Type	HUMAN OTC DRUG
Dosage Form	SWAB
Route	TOPICAL
Active Ingredient Strength	70
Active Ingredient Units	g/100g
Substance Name	ISOPROPYL ALCOHOL
Labeler Name	Acme United Corporation
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part333A
Listing Certified Through	2024-12-31

Package

Package Images

NDC 00924-0009-00 (00924000900)

Pricing Information	N/A
NDC Package Code	0924-0009-00
Billing NDC	00924000900
Package	1 g in 1 PACKET (0924-0009-00)
Marketing Start Date	2017-07-26
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 55421010-d806-4ca4-e054-00144ff88e88 Details

Active Ingredients

Active Ingredients Isopropyl Alcohol 70%

Purpose

Antispetic Cleanser

Uses

Uses •For preparation of the skin prior to injection

Warnings

Warnings • For external use only.

•Flammable, keep away from fire or flame

Do Not Use

Do not use • with electrocautery procedures

•In the eyes. If contact occurs, flush eyes with water

Stop use

Stop Use if irritation or redness develop.If condition persists consult your health care practicioner.

Keep out of reach of children

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

Directions

Directions •Wipe Injection site vigorously and discard.

Inactive Ingredients

Inactive Ingredients purified water

Package Label Principal Display Panel

INGREDIENTS AND APPEARANCE

FIRST AID ONLY ALCOHOL ANTISEPTIC PAD

alcohol pad swab

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0924-0009(NDC:71310-200)
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302)	ISOPROPYL ALCOHOL	70 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:0924-0009-00	1 g in 1 PACKET; Type 0: Not a Combination Product	07/26/2017
2	NDC:0924-0009-01	100 in 1 CARTON	06/28/2018
2		1 g in 1 PACKET; Type 0: Not a Combination Product
3	NDC:0924-0009-02	200 in 1 CARTON	06/28/2018
3		1 g in 1 PACKET; Type 0: Not a Combination Product
4	NDC:0924-0009-03	10 in 1 CARTON	01/22/2019
4		1 g in 1 PACKET; Type 0: Not a Combination Product
5	NDC:0924-0009-04	20 in 1 CARTON	01/22/2019
5		1 g in 1 PACKET; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	07/26/2017

Labeler - Acme United Corporation (001180207)

Name	Address	ID/FEI	Business Operations
Establishment
Acme United Corporation		045924339	relabel(0924-0009) , repack(0924-0009)

Name	Address	ID/FEI	Business Operations
Establishment
Acme United Corporation		080119599	repack(0924-0009) , relabel(0924-0009)

Revised: 1/2019

Document Id: 801168e9-ebef-fe3a-e053-2991aa0a1eb0

Set id: 55421010-d806-4ca4-e054-00144ff88e88

Version: 3

Effective Time: 20190122