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NDC 58503-0803-04 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 China Ningbo Shangge Cosmetic Technology Corp.. The primary component is ALCOHOL.

Product Information

NDC	58503-0803
Product ID	58503-803_a7b86322-5a4c-15d7-e053-2a95a90a5d33
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	China Ningbo Shangge Cosmetic Technology Corp.
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 58503-0803-04 (58503080304)

Pricing Information	N/A
NDC Package Code	58503-803-04
Billing NDC	58503080304
Package	3785 mL in 1 BOTTLE (58503-803-04)
Marketing Start Date	2020-03-30
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL a7b86322-5a4d-15d7-e053-2a95a90a5d33 Details

Active Ingredient(s)

Ethyl Alcohol 70.0%V/v

Purpose

Antimicrobial

Use

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

Warnings

For external use only

Flammable, keep away from heat and flame.

Do not use

● on infants

● on open skin wounds

SPL UNCLASSIFIED SECTION

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

SPL UNCLASSIFIED SECTION

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

Directions

● Apply as needed into palm of hand and thoroughly spread on both hands, rub until dry.

● Supervise children under 6 years of age when using this product.

Other information

● Store between15-30°c(59-86°F)

● Avoid freezing and excessive heat above40°c(104°F)

Inactive ingredients

Deionized water, Triethanolamine, Carbomer,Propylene Glycol, Glycerin, Aloe Barbadensis Leaf Juice, Tocophe Acetate

Package Label - Principal Display Panel

INGREDIENTS AND APPEARANCE

HAND SANITIZER

hand sanitizer gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:58503-803
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)
GLYCERIN (UNII: PDC6A3C0OX)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
WATER (UNII: 059QF0KO0R)
.ALPHA.-TOCOPHEROL SUCCINATE, D- (UNII: LU4B53JYVE)
TROLAMINE (UNII: 9O3K93S3TK)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:58503-803-01	60 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
2	NDC:58503-803-02	237 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
3	NDC:58503-803-03	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
4	NDC:58503-803-04	3785 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 - China Ningbo Shangge Cosmetic Technology Corp. (529287434)

Name	Address	ID/FEI	Business Operations
Establishment
China Ningbo Shangge Cosmetic Technology Corp.		529287434	manufacture(58503-803)

Revised: 6/2020

Document Id: a7b86322-5a4c-15d7-e053-2a95a90a5d33

Set id: a7b86322-5a4d-15d7-e053-2a95a90a5d33

Version: 1

Effective Time: 20200610

Search by Drug Name or NDC

NDC 58503-0803-04 Hand Sanitizer 75 mL/100mL Details

Hand Sanitizer 75 mL/100mL

Product Information

Package

Package Images

NDC 58503-0803-04 (58503080304)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL a7b86322-5a4d-15d7-e053-2a95a90a5d33 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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