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NDC 00924-0017-01 First Aid Only Alcohol Antiseptic 70 mL/100mL Details

First Aid Only Alcohol Antiseptic 70 mL/100mL

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

Product Information

NDC	00924-0017
Product ID	0924-0017_a810e723-ad0d-8c71-e053-2995a90a0acc
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
Proprietary Name Suffix	n/a
Non-Proprietary Name	ISOPROPYL ALCOHOL
Product Type	HUMAN OTC DRUG
Dosage Form	LIQUID
Route	TOPICAL
Active Ingredient Strength	70
Active Ingredient Units	mL/100mL
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 00924-0017-01 (00924001701)

Pricing Information	N/A
NDC Package Code	0924-0017-01
Billing NDC	00924001701
Package	.4 mL in 1 POUCH (0924-0017-01)
Marketing Start Date	2020-06-15
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL a810e723-ad0c-8c71-e053-2995a90a0acc Details

First Aid Only Alcohol Antiseptic Pad

Active ingredient

Isopropyl Alcohol, 70% v/v

Purpose

Antiseptic Cleanser

Use

For preparation of the skin prior to an injection.

Warnings

For external use only. Flammable, keep away from fire or flame.

Do not use

with electrocautery procedures
in the eyes. If contact occurs, flush eyes with water

Stop use

if irritation and redness develop. . If condition persists consult your health care practitioner.

Keep out of reach of children.

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

Directions

Wipe injection site vigorously and discard.

Other information

Store at room temperature 15 - 30°C (59 - 86°F)

Inactive ingredient

Purified Water

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

FIRST AID ONLY ALCOHOL ANTISEPTIC

isopropyl alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0924-0017(NDC:59050-444)
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 mL in 100 mL

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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0924-0017-01	0.4 mL in 1 POUCH; Type 0: Not a Combination Product	06/15/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	06/15/2020

Labeler - Acme United Corporation (001180207)

Name	Address	ID/FEI	Business Operations
Establishment
Acme United Corporation		045924339	relabel(0924-0017) , repack(0924-0017)

Name	Address	ID/FEI	Business Operations
Establishment
Acme United Corporation		080119599	relabel(0924-0017) , repack(0924-0017)

Revised: 6/2020

Document Id: a810e723-ad0d-8c71-e053-2995a90a0acc

Set id: a810e723-ad0c-8c71-e053-2995a90a0acc

Version: 1

Effective Time: 20200614