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NDC 70082-0002-01 Alcohol 0.7 mL/mL Details

Alcohol 0.7 mL/mL

Alcohol is a TOPICAL SWAB in the HUMAN OTC DRUG category. It is labeled and distributed by Dealmed Medical Supplies LLC. The primary component is ISOPROPYL ALCOHOL.

Product Information

NDC	70082-0002
Product ID	70082-002_edc0c496-fac1-21e1-e053-2a95a90a85d6
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	Alcohol
Proprietary Name Suffix	n/a
Non-Proprietary Name	Alcohol
Product Type	HUMAN OTC DRUG
Dosage Form	SWAB
Route	TOPICAL
Active Ingredient Strength	0.7
Active Ingredient Units	mL/mL
Substance Name	ISOPROPYL ALCOHOL
Labeler Name	Dealmed Medical Supplies LLC
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part333A
Listing Certified Through	2023-12-31

Package

Package Images

NDC 70082-0002-01 (70082000201)

Pricing Information	N/A
NDC Package Code	70082-002-01
Billing NDC	70082000201
Package	50 POUCH in 1 BOX (70082-002-01) / 1.4 mL in 1 POUCH
Marketing Start Date	2015-09-15
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 7c646335-f454-4d90-b91b-e7c444955fa7 Details

SPL UNCLASSIFIED SECTION

Active Ingredient Purpose

Isopropyl Alcohol 70% v/v Antiseptic

Use:

For preparation of the skin prior to injection.

Warnings:

For external use only
Flammable, keep away from flame or fire
Not for use with electrocautinary devices or procedures
Do not use in eyes

Indications and Usage:

Stop use and ask a doctor if:

Irritation or redness develops
condition persists for more than 72 hours
Cleansing of an injection site

Keep out of reach of children.

In case of accidental ingestion, seek professional assistance or consult a poison control center immediately.

Directions:

Wipe injection site vigorously and discard

Other information:

Store at room temperature: 15 deg C to 30 deg C 59 deg F to 86 deg F
avoid excessive heat

Inactive Ingredient

Water

Principal Display Panel

Dealmed Alcohol Swabstick

INGREDIENTS AND APPEARANCE

ALCOHOL

alcohol swab

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:70082-002
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302)	ISOPROPYL ALCOHOL	0.7 mL in 1 mL

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

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:70082-002-01	50 in 1 BOX	09/15/2015
1		1.4 mL in 1 POUCH; Type 0: Not a Combination Product
2	NDC:70082-002-02	75 in 1 BOX	09/15/2015
2		1.4 mL in 1 POUCH; 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	09/15/2015

Labeler - Dealmed Medical Supplies LLC (068586441)

Revised: 11/2022

Document Id: edc0c496-fac1-21e1-e053-2a95a90a85d6

Set id: 7c646335-f454-4d90-b91b-e7c444955fa7

Version: 5

Effective Time: 20221118