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NDC 70082-0003-10 Sterile Alcohol Prep Pads 0.7 mL/mL Details

Sterile Alcohol Prep Pads 0.7 mL/mL

Sterile Alcohol Prep Pads is a TOPICAL SWAB in the HUMAN OTC DRUG category. It is labeled and distributed by DEALMED. The primary component is ISOPROPYL ALCOHOL.

Product Information

NDC	70082-0003
Product ID	70082-003_edc0758e-0f7b-0e50-e053-2a95a90a61a7
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	Sterile Alcohol Prep Pads
Proprietary Name Suffix	n/a
Non-Proprietary Name	Alcohol Prep Pad
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
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 70082-0003-10 (70082000310)

Pricing Information	N/A
NDC Package Code	70082-003-10
Billing NDC	70082000310
Package	4000 BOX in 1 CASE (70082-003-10) / 400 POUCH in 1 BOX / 3 mL in 1 POUCH
Marketing Start Date	2019-03-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 908e1b28-4b84-6312-e053-2995a90a7b19 Details

Active ingredient

Isopropyl Alcohol 70%

Purpose

Antiseptic

Uses

First aid to help prevent infection in minor cuts, scrapes and burns
For preparation of the skin prior to an injection

Warnings

For External Use Only

Flammable. Keep away from fire or flame

Do not use

in the eyes or over large areas of the body
longer than 1 week unless directed by a doctor
with electrocautery procedures

Ask a doctor before use if you have

deep or puncture wounds, animal bites, or serious burns

Stop use and ask a doctor if

condition persists for more than 72 hours or gets worse

Keep out of reach of children.

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

Directions

When used for first aid: Clean the affected area. Apply a small amount of this product on the area 1 to 3 times daily. May be covered with a sterile bandage. If bandaged, let dry first.
When used to prepare an injection site: Apply product to the injection site prior to injection.

Other information

Store at room temperature
Avoid excessive heat

Inactive ingredient

Water

Label

INGREDIENTS AND APPEARANCE

STERILE ALCOHOL PREP PADS

alcohol prep pad swab

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:70082-003
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:70082-003-10	4000 in 1 CASE	03/01/2019
1		400 in 1 BOX
1		3 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	03/01/2019

Labeler - DEALMED (068586441)

Revised: 11/2022

Document Id: edc0758e-0f7b-0e50-e053-2a95a90a61a7

Set id: 908e1b28-4b84-6312-e053-2995a90a7b19

Version: 4

Effective Time: 20221118