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NDC 81991-0002-37 Antibacterial Wet Wipes 0.13 g/100g Details

Antibacterial Wet Wipes 0.13 g/100g

Antibacterial Wet Wipes is a TOPICAL CLOTH in the HUMAN OTC DRUG category. It is labeled and distributed by Antibacterial Wet Wipes. The primary component is BENZALKONIUM CHLORIDE.

Product Information

NDC	81991-0002
Product ID	81991-002_d4fac175-e017-74dd-e053-2a95a90a1aac
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	Antibacterial Wet Wipes
Proprietary Name Suffix	n/a
Non-Proprietary Name	Antibacterial Wet Wipes
Product Type	HUMAN OTC DRUG
Dosage Form	CLOTH
Route	TOPICAL
Active Ingredient Strength	0.13
Active Ingredient Units	g/100g
Substance Name	BENZALKONIUM CHLORIDE
Labeler Name	Antibacterial Wet Wipes
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 81991-0002-37 (81991000237)

Pricing Information	N/A
NDC Package Code	81991-002-37
Billing NDC	81991000237
Package	65 POUCH in 1 CANISTER (81991-002-37) / .0042 g in 1 POUCH
Marketing Start Date	2022-01-06
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL d4be346a-7bc4-3fd3-e053-2a95a90ad793 Details

SPL UNCLASSIFIED SECTION

Benzalkonium chloride 0.13%

SPL UNCLASSIFIED SECTION

Antibacterial Wet Wipes

SPL UNCLASSIFIED SECTION

For hand sanitizing to decrease bacteria on the skin,kills 99.9% common germs

SPL UNCLASSIFIED SECTION

For external Use only

SPL UNCLASSIFIED SECTION

When use this product avoid contact with the eyes.In case of contact, flush eyes thoroughly with water.

SPL UNCLASSIFIED SECTION

Stop use and ask a doctor if irritation or redness develop

SPL UNCLASSIFIED SECTION

Keep out of reach of children. If swallowed,get medical help or contact a Poison Control Center right away.

SPL UNCLASSIFIED SECTION

Directions

Take wipe and rub thoroughly over all surfaces of both hands

Rub hands together briskly to dry

Dispose of wipes

SPL UNCLASSIFIED SECTION

Water,Glycerin, Disodium Cocoamphodiacetate, Phenoxyethanol, Benzoic Acid, Polysorbate 20, Potassium Sorbate, Aloe Barbadensis Leaf Juice, Sodium Citrate

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ANTIBACTERIAL WET WIPES

antibacterial wet wipes cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:81991-002
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.13 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
ALOE VERA LEAF (UNII: ZY81Z83H0X)
WATER (UNII: 059QF0KO0R)
DISODIUM COCOAMPHODIACETATE (UNII: 18L9G3U51M)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
BENZOIC ACID (UNII: 8SKN0B0MIM)
GLYCERIN (UNII: PDC6A3C0OX)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
SODIUM CITRATE (UNII: 1Q73Q2JULR)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:81991-002-01	65 g in 1 BOTTLE; Type 0: Not a Combination Product	12/30/2021
2	NDC:81991-002-02	70 g in 1 BOTTLE; Type 0: Not a Combination Product	12/30/2021
3	NDC:81991-002-03	75 g in 1 BOTTLE; Type 0: Not a Combination Product	12/30/2021	12/30/2021
4	NDC:81991-002-04	80 g in 1 BOTTLE; Type 0: Not a Combination Product	12/30/2021	12/30/2021
5	NDC:81991-002-05	100 g in 1 BOTTLE; Type 0: Not a Combination Product	12/30/2021	12/30/2021
6	NDC:81991-002-06	160 g in 1 BOTTLE; Type 0: Not a Combination Product	12/30/2021	12/30/2021
7	NDC:81991-002-07	250 g in 1 BOTTLE; Type 0: Not a Combination Product	12/30/2021	12/30/2021
8	NDC:81991-002-17	700 g in 1 BAG; Type 0: Not a Combination Product	01/04/2022	01/04/2022
9	NDC:81991-002-18	800 g in 1 BAG; Type 0: Not a Combination Product	01/04/2022	01/04/2022
10	NDC:81991-002-19	900 g in 1 BAG; Type 0: Not a Combination Product	01/04/2022	01/04/2022
11	NDC:81991-002-20	1000 g in 1 BAG; Type 0: Not a Combination Product	01/04/2022	01/04/2022
12	NDC:81991-002-21	1100 g in 1 BAG; Type 0: Not a Combination Product	01/04/2022	01/04/2022
13	NDC:81991-002-22	1200 g in 1 BAG; Type 0: Not a Combination Product	01/04/2022	01/04/2022
14	NDC:81991-002-23	1 g in 1 BAG; Type 0: Not a Combination Product	01/04/2022	01/04/2022
15	NDC:81991-002-24	10 g in 1 BAG; Type 0: Not a Combination Product	01/04/2022	01/04/2022
16	NDC:81991-002-25	15 g in 1 BAG; Type 0: Not a Combination Product	01/04/2022	01/04/2022
17	NDC:81991-002-26	30 g in 1 BAG; Type 0: Not a Combination Product	01/04/2022	01/04/2022
18	NDC:81991-002-27	50 g in 1 BAG; Type 0: Not a Combination Product	01/04/2022	01/04/2022
19	NDC:81991-002-28	80 g in 1 BAG; Type 0: Not a Combination Product	12/30/2021	12/30/2021
20	NDC:81991-002-29	100 g in 1 BAG; Type 0: Not a Combination Product	01/04/2022	01/04/2022
21	NDC:81991-002-30	700 g in 1 BOTTLE; Type 0: Not a Combination Product	01/04/2022	01/04/2022
22	NDC:81991-002-31	800 g in 1 BOTTLE; Type 0: Not a Combination Product	01/04/2022	01/04/2022
23	NDC:81991-002-32	900 g in 1 BOTTLE; Type 0: Not a Combination Product	01/04/2022	01/04/2022
24	NDC:81991-002-33	1000 g in 1 BOTTLE; Type 0: Not a Combination Product	01/04/2022	01/04/2022
25	NDC:81991-002-34	1200 g in 1 BOTTLE; Type 0: Not a Combination Product	01/04/2022	01/04/2022
26	NDC:81991-002-35	1500 g in 1 BOTTLE; Type 0: Not a Combination Product	01/04/2022	01/04/2022
27	NDC:81991-002-36	1500 g in 1 BAG; Type 0: Not a Combination Product	01/04/2022	01/04/2022

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	12/30/2021

Labeler - Antibacterial Wet Wipes (699294784)

Name	Address	ID/FEI	Business Operations
Establishment
Hangzhou Jiexiang Technology Co., Ltd		699294784	manufacture(81991-002)

Revised: 1/2022

Document Id: d4fac175-e017-74dd-e053-2a95a90a1aac

Set id: d4be346a-7bc4-3fd3-e053-2a95a90ad793

Version: 14

Effective Time: 20220107

Search by Drug Name or NDC

NDC 81991-0002-37 Antibacterial Wet Wipes 0.13 g/100g Details

Antibacterial Wet Wipes 0.13 g/100g

Product Information

Package

Package Images

NDC 81991-0002-37 (81991000237)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL d4be346a-7bc4-3fd3-e053-2a95a90ad793 Details

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PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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