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NDC 52985-0900-05 alcohol wipes 75 mL/100mL Details

alcohol wipes 75 mL/100mL

alcohol wipes is a TOPICAL CLOTH in the HUMAN OTC DRUG category. It is labeled and distributed by Anhui Oasis Disinfection Products Co., Ltd. The primary component is ALCOHOL.

Product Information

NDC	52985-0900
Product ID	52985-900_d597c7c8-4c59-94e0-e053-2995a90a53fc
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 wipes
Proprietary Name Suffix	n/a
Non-Proprietary Name	Ethyl Alcohol
Product Type	HUMAN OTC DRUG
Dosage Form	CLOTH
Route	TOPICAL
Active Ingredient Strength	75
Active Ingredient Units	mL/100mL
Substance Name	ALCOHOL
Labeler Name	Anhui Oasis Disinfection Products Co., Ltd
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part333E
Listing Certified Through	2023-12-31

Package

Package Images

NDC 52985-0900-05 (52985090005)

Pricing Information	N/A
NDC Package Code	52985-900-05
Billing NDC	52985090005
Package	40 BAG in 1 CARTON (52985-900-05) / 50 POUCH in 1 BAG / 243 mL in 1 POUCH
Marketing Start Date	2020-06-18
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL a87a6963-96b9-2226-e053-2995a90aa3dc Details

Active Ingredient

Ethyl Alcohol 75%

Purpose

Sanitizing

Use

Wipes to sanitize surfaces.

SPL UNCLASSIFIED SECTION

Flammable, keep it away from fire or flame. . For External use only, DO not use on face or open wound

1 Keep out of reach of children■Do not flush down to toilet

Avoid Discontinue use immediately if rash or irritation appears

■Keep out of reach of children.

Directions

Open the package lid, tear off the inner seal, remove the alcohol based wipes to apply to sanitize surfaces. Discard used wipes in trash after use, do not flush in toilet.

Inactive ingredients

Purified water, Glycerol, Citric Acid

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ALCOHOL WIPES

ethyl alcohol cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:52985-900
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	75 mL in 100 mL

Ingredient Name	Strength
Inactive Ingredients
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:52985-900-01	1000 in 1 CARTON	06/18/2020
1		1 in 1 BAG
1		4.86 mL in 1 POUCH; Type 0: Not a Combination Product
2	NDC:52985-900-02	200 in 1 CARTON	06/18/2020
2		10 in 1 BAG
2		48.6 mL in 1 POUCH; Type 0: Not a Combination Product
3	NDC:52985-900-03	100 in 1 CARTON	06/18/2020
3		30 in 1 BOX
3		145.8 mL in 1 POUCH; Type 0: Not a Combination Product
4	NDC:52985-900-04	50 in 1 CARTON	06/18/2020
4		40 in 1 BAG
4		194.4 mL in 1 POUCH; Type 0: Not a Combination Product
5	NDC:52985-900-05	40 in 1 CARTON	06/18/2020
5		50 in 1 BAG
5		243 mL in 1 POUCH; Type 0: Not a Combination Product
6	NDC:52985-900-06	40 in 1 CARTON	06/18/2020
6		60 in 1 BAG
6		291.6 mL in 1 POUCH; Type 0: Not a Combination Product
7	NDC:52985-900-07	30 in 1 CARTON	06/18/2020
7		80 in 1 BAG
7		388.8 mL in 1 POUCH; Type 0: Not a Combination Product
8	NDC:52985-900-08	20 in 1 CARTON	06/18/2020
8		100 in 1 BAG
8		486 mL in 1 POUCH; Type 0: Not a Combination Product
9	NDC:52985-900-09	20 in 1 CARTON	06/18/2020
9		120 in 1 BAG
9		583.2 mL in 1 POUCH; Type 0: Not a Combination Product
10	NDC:52985-900-10	10 in 1 CARTON	06/18/2020
10		150 in 1 BOX
10		729 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	part333E	06/18/2020

Labeler - Anhui Oasis Disinfection Products Co., Ltd (529664312)

Name	Address	ID/FEI	Business Operations
Establishment
Anhui Oasis Disinfection Products Co., Ltd		529664312	manufacture(52985-900)

Revised: 1/2022

Document Id: d597c7c8-4c59-94e0-e053-2995a90a53fc

Set id: a87a6963-96b9-2226-e053-2995a90aa3dc

Version: 3

Effective Time: 20220114