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NDC 77060-0101-02 HAND SANITIZER 75 mL/100mL Details

HAND SANITIZER 75 mL/100mL

HAND SANITIZER is a TOPICAL GEL in the HUMAN OTC DRUG category. It is labeled and distributed by Zhejiang Beta Industry And Trade Co., Ltd.. The primary component is ALCOHOL.

Product Information

NDC	77060-0101
Product ID	77060-101_dc71e0b6-145a-0968-e053-2995a90aa4fe
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	HAND SANITIZER
Proprietary Name Suffix	n/a
Non-Proprietary Name	HAND SANITIZER
Product Type	HUMAN OTC DRUG
Dosage Form	GEL
Route	TOPICAL
Active Ingredient Strength	75
Active Ingredient Units	mL/100mL
Substance Name	ALCOHOL
Labeler Name	Zhejiang Beta Industry And Trade Co., Ltd.
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 77060-0101-02 (77060010102)

Pricing Information	N/A
NDC Package Code	77060-101-02
Billing NDC	77060010102
Package	60 mL in 1 BOTTLE (77060-101-02)
Marketing Start Date	2020-03-30
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL a4838638-b51d-9d6c-e053-2995a90a4ebb Details

Active Ingredient(s)

Ethyl Alcohol 75.0%Antimicrobia

Purpose

Antimicrobial

Use

Uses help reduce bacteria on the skin.

Warnings

Do not use

in children less than 2 months of age
on open skin wounds

SPL UNCLASSIFIED SECTION

When using this product avoid contact with face, eyes, and broken skin, In case of eye contact, flush with plenty of water and seek medical advice

SPL UNCLASSIFIED SECTION

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

SPL UNCLASSIFIED SECTION

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

Directions

Directions: wet hands thoroughly with product and rubinto skin until dry. Children under 6 years of age should be supervised by an adult when using

Other information

Store between 15-30C (59-86F)
Avoid freezing and excessive heat above 40C (104F)

Inactive ingredients

water(aqua), triethanolamine, carbomer, aloealoe barbadensis(aloe vera)leaf juice,fragrance, glycerin, propylene glycol,tocopherol Acetate(Vitamin E)

Package Label - Principal Display Panel

INGREDIENTS AND APPEARANCE

HAND SANITIZER

hand sanitizer gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:77060-101
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
ALOE VERA LEAF (UNII: ZY81Z83H0X)
WATER (UNII: 059QF0KO0R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)
TROLAMINE (UNII: 9O3K93S3TK)
GLYCERIN (UNII: PDC6A3C0OX)
CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:77060-101-01	50 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020	04/12/2022
2	NDC:77060-101-02	60 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
3	NDC:77060-101-03	80 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020	04/12/2022
4	NDC:77060-101-04	100 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020	04/12/2022
5	NDC:77060-101-05	150 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020	04/12/2022
6	NDC:77060-101-06	235 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020	04/12/2022
7	NDC:77060-101-07	250 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020	04/12/2022
8	NDC:77060-101-08	300 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020	04/12/2022
9	NDC:77060-101-09	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020	04/12/2022
10	NDC:77060-101-10	1000 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020	04/12/2022
11	NDC:77060-101-11	30 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	03/30/2020

Labeler - Zhejiang Beta Industry And Trade Co., Ltd. (411892770)

Registrant - Zhejiang Beta Industry And Trade Co., Ltd. (411892770)

Name	Address	ID/FEI	Business Operations
Establishment
Zhejiang Beta Industry And Trade Co., Ltd.		411892770	manufacture(77060-101)

Revised: 4/2022

Document Id: dc71e0b6-145a-0968-e053-2995a90aa4fe

Set id: a4838638-b51d-9d6c-e053-2995a90a4ebb

Version: 4

Effective Time: 20220412

Search by Drug Name or NDC

NDC 77060-0101-02 HAND SANITIZER 75 mL/100mL Details

HAND SANITIZER 75 mL/100mL

Product Information

Package

Package Images

NDC 77060-0101-02 (77060010102)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL a4838638-b51d-9d6c-e053-2995a90a4ebb Details

Active Ingredient(s)

Purpose

Use

Warnings

Do not use

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

Directions

Other information

Inactive ingredients

Package Label - Principal Display Panel

INGREDIENTS AND APPEARANCE

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