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NDC 77050-0016-11 Hand Sanitizer 70 mL/100mL Details

Hand Sanitizer 70 mL/100mL

Hand Sanitizer is a TOPICAL GEL in the HUMAN OTC DRUG category. It is labeled and distributed by Global Exports U.S.A., Inc.. The primary component is ALCOHOL.

Product Information

NDC	77050-0016
Product ID	77050-016_466b3a65-87cd-48be-938d-0c8faaabb7be
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	ALCOHOL
Product Type	HUMAN OTC DRUG
Dosage Form	GEL
Route	TOPICAL
Active Ingredient Strength	70
Active Ingredient Units	mL/100mL
Substance Name	ALCOHOL
Labeler Name	Global Exports U.S.A., Inc.
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 77050-0016-11 (77050001611)

Pricing Information	N/A
NDC Package Code	77050-016-11
Billing NDC	77050001611
Package	18927 mL in 1 CONTAINER (77050-016-11)
Marketing Start Date	2020-07-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL a73b51d2-9bc4-74ce-e053-2a95a90a0445 Details

Active Ingredient

Alcohol 70% v/v

Purpose

Antiseptic

Uses

Hand sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Warnings

For external use only. Flammable. Keep away from heat or flame

Do not use

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

SPL UNCLASSIFIED SECTION

When using this product do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.

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 right away.

Directions

Put enough product in your palm to cover hands and rub hands together briskly until dry.
Children under 6 years of age should be supervised when using products.

Other information

Store below 110°F(43C°)
Avoid freezing and excessive heat above 104°F(40°C)
May discolor certain fabrics or surfaces

Inactive ingredients

Aloe Vera, Carbomer Interpolymer (type B), Glycerin, Lemon oil, Triethanolamine, Water (Aqua)

Package Label - Principal Display Panel

INGREDIENTS AND APPEARANCE

HAND SANITIZER

alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:77050-016
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	70 mL in 100 mL

Ingredient Name	Strength
Inactive Ingredients
Lemon Oil (UNII: I9GRO824LL)
Glycerin (UNII: PDC6A3C0OX)
Trolamine (UNII: 9O3K93S3TK)
Water (UNII: 059QF0KO0R)
Aloe Vera Leaf (UNII: ZY81Z83H0X)
Carbomer Interpolymer Type B (Allyl Pentaerythritol Crosslinked) (UNII: 132584PQMO)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:77050-016-01	473 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	06/04/2020
2	NDC:77050-016-02	59 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/01/2020
3	NDC:77050-016-03	118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/01/2020
4	NDC:77050-016-04	237 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	07/01/2020
5	NDC:77050-016-05	946 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	07/01/2020
6	NDC:77050-016-06	1893 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/01/2020
7	NDC:77050-016-07	1893 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	07/01/2020
8	NDC:77050-016-08	3785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/01/2020
9	NDC:77050-016-09	3785 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	07/01/2020
10	NDC:77050-016-10	18927 mL in 1 CONTAINER; Type 0: Not a Combination Product	07/01/2020
11	NDC:77050-016-11	18927 mL in 1 CONTAINER; Type 0: Not a Combination Product	07/01/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	06/04/2020

Labeler - Global Exports U.S.A., Inc. (607803517)

Name	Address	ID/FEI	Business Operations
Establishment
Global Exports U.S.A., Inc.		607803517	PACK(77050-016) , LABEL(77050-016)

Revised: 6/2020

Document Id: 466b3a65-87cd-48be-938d-0c8faaabb7be

Set id: a73b51d2-9bc4-74ce-e053-2a95a90a0445

Version: 2

Effective Time: 20200623

Search by Drug Name or NDC

NDC 77050-0016-11 Hand Sanitizer 70 mL/100mL Details

Hand Sanitizer 70 mL/100mL

Product Information

Package

Package Images

NDC 77050-0016-11 (77050001611)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL a73b51d2-9bc4-74ce-e053-2a95a90a0445 Details

Active Ingredient

Purpose

Uses

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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