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NDC 42339-0001-01 Alcohol Prep Pad 0.7 mL/1 Details

Alcohol Prep Pad 0.7 mL/1

Alcohol Prep Pad is a TOPICAL SWAB in the HUMAN OTC DRUG category. It is labeled and distributed by Shandong Haiyan Medical Manufacture Co., Ltd.. The primary component is ISOPROPYL ALCOHOL.

Product Information

NDC	42339-0001
Product ID	42339-001_c917a103-9722-22c9-e053-2a95a90a9779
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 Prep Pad
Proprietary Name Suffix	n/a
Non-Proprietary Name	Isopropyl Alcohol
Product Type	HUMAN OTC DRUG
Dosage Form	SWAB
Route	TOPICAL
Active Ingredient Strength	0.7
Active Ingredient Units	mL/1
Substance Name	ISOPROPYL ALCOHOL
Labeler Name	Shandong Haiyan Medical Manufacture Co., Ltd.
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part344
Listing Certified Through	2024-12-31

Package

Package Images

NDC 42339-0001-01 (42339000101)

Pricing Information	N/A
NDC Package Code	42339-001-01
Billing NDC	42339000101
Package	15 BOX in 1 CONTAINER (42339-001-01) / 200 SWAB in 1 BOX
Marketing Start Date	2017-12-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 1a117840-22d0-4a88-b1a6-e43162a444ab Details

Active Ingredient

Isopropyl Alcohol 70%v/v

Purpose

Antiseptic

Use

For preparation of skin prior to injection.

WARNINGS

For External use only.

Flammable,keep away from fire or flame.

Do not use with electrocautery procedures in eyes.

Stop use and ask a doctor if irritation and redness develop,condition persists for more than 72 hours .

keep out of reach of children

In case of accidental ingestion, seek professional assistance or consult a PoisonControl Center immediately.

Directions

Wipe injection site vigorously and discard.

Inactive ingredients

purified water

PRINCIPAL DISPLAY PANEL

section text here

INGREDIENTS AND APPEARANCE

ALCOHOL PREP PAD

isopropyl alcohol swab

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:42339-001
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

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

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:42339-001-01	15 in 1 CONTAINER	12/01/2017
1		200 in 1 BOX; Type 0: Not a Combination Product
2	NDC:42339-001-04	100 in 1 CONTAINER	12/01/2017
2		50 in 1 BOX; Type 0: Not a Combination Product
3	NDC:42339-001-02	100 in 1 CONTAINER	12/01/2017
3		100 in 1 BOX; Type 0: Not a Combination Product
4	NDC:42339-001-03	3000 in 1 CONTAINER; Type 0: Not a Combination Product	12/01/2017
5	NDC:42339-001-05	30 in 1 CASE	12/01/2017
5		36 in 1 BOX; Type 0: Not a Combination Product
6	NDC:42339-001-06	24 in 1 CASE	12/01/2017
6		50 in 1 BOX; Type 0: Not a Combination Product
7	NDC:42339-001-07	24 in 1 CASE	12/01/2017
7		100 in 1 BOX; Type 0: Not a Combination Product
8	NDC:42339-001-08	20 in 1 CASE	12/01/2017
8		140 in 1 BOX; Type 0: Not a Combination Product
9	NDC:42339-001-09	30 in 1 CASE	12/01/2017
9		100 in 1 BOX; Type 0: Not a Combination Product
10	NDC:42339-001-10	15 in 1 CASE	12/01/2017
10		200 in 1 BOX; Type 0: Not a Combination Product
11	NDC:42339-001-11	20 in 1 CASE	12/01/2017
11		200 in 1 BOX; Type 0: Not a Combination Product
12	NDC:42339-001-12	12 in 1 CASE	12/01/2017
12		100 in 1 BOX; Type 0: Not a Combination Product
13	NDC:42339-001-13	48 in 1 CASE	12/01/2017
13		200 in 1 BOX; Type 0: Not a Combination Product
14	NDC:42339-001-14	20 in 1 CASE	12/01/2017
14		200 in 1 BOX; Type 0: Not a Combination Product
15	NDC:42339-001-15	24 in 1 CASE	12/01/2017
15		400 in 1 BOX; Type 0: Not a Combination Product
16	NDC:42339-001-16	20 in 1 CASE	12/01/2017
16		50 in 1 BOX; Type 0: Not a Combination Product
17	NDC:42339-001-17	20 in 1 CASE	12/01/2017
17		200 in 1 BOX; Type 0: Not a Combination Product
18	NDC:42339-001-18	4 in 1 CASE	12/01/2017
18		1000 in 1 BOX; Type 0: Not a Combination Product
19	NDC:42339-001-19	20 in 1 CASE	12/01/2017
19		200 in 1 BOX; Type 0: Not a Combination Product
20	NDC:42339-001-20	10 in 1 CASE	12/01/2017
20		100 in 1 BOX; Type 0: Not a Combination Product
21	NDC:42339-001-21	30 in 1 CASE	12/01/2017
21		36 in 1 BOX; Type 0: Not a Combination Product
22	NDC:42339-001-22	20 in 1 CASE	12/01/2017
22		80 in 1 BOX; Type 0: Not a Combination Product
23	NDC:42339-001-23	15 in 1 CASE	12/01/2017
23		120 in 1 BOX; Type 0: Not a Combination Product
24	NDC:42339-001-24	20 in 1 CASE	12/01/2017
24		100 in 1 BOX; Type 0: Not a Combination Product
25	NDC:42339-001-25	30 in 1 CASE	12/01/2017
25		100 in 1 BOX; Type 0: Not a Combination Product
26	NDC:42339-001-26	30 in 1 CASE	12/01/2017
26		140 in 1 BOX; Type 0: Not a Combination Product
27	NDC:42339-001-27	30 in 1 CASE	12/01/2017
27		200 in 1 BOX; Type 0: Not a Combination Product
28	NDC:42339-001-28	96 in 1 CASE	12/01/2017
28		100 in 1 BOX; Type 0: Not a Combination Product
29	NDC:42339-001-29	10 in 1 CASE	12/01/2017
29		100 in 1 BOX; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part344	02/18/2012

Labeler - Shandong Haiyan Medical Manufacture Co., Ltd. (421283439)

Name	Address	ID/FEI	Business Operations
Establishment
Shandong Haiyan Medical Manufacture Co., Ltd.		421283439	manufacture(42339-001)

Revised: 8/2021

Document Id: c917a103-9722-22c9-e053-2a95a90a9779

Set id: 1a117840-22d0-4a88-b1a6-e43162a444ab

Version: 5

Effective Time: 20210808