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NDC 59228-0501-16 INSTANT HAND SANITIZER WITH ALOE 66.5 mL/100mL Details

INSTANT HAND SANITIZER WITH ALOE 66.5 mL/100mL

INSTANT HAND SANITIZER WITH ALOE is a TOPICAL GEL in the HUMAN OTC DRUG category. It is labeled and distributed by Ems Acquisition Corp.. The primary component is ALCOHOL.

Product Information

NDC	59228-0501
Product ID	59228-501_ecfa9109-e93e-ad4e-e053-2a95a90a372b
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	INSTANT HAND SANITIZER WITH ALOE
Proprietary Name Suffix	66.5% ETHYL ALCOHOL
Non-Proprietary Name	ETHYL ALCOHOL
Product Type	HUMAN OTC DRUG
Dosage Form	GEL
Route	TOPICAL
Active Ingredient Strength	66.5
Active Ingredient Units	mL/100mL
Substance Name	ALCOHOL
Labeler Name	Ems Acquisition Corp.
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part333A
Listing Certified Through	2024-12-31

Package

Package Images

NDC 59228-0501-16 (59228050116)

Pricing Information	N/A
NDC Package Code	59228-501-16
Billing NDC	59228050116
Package	473 mL in 1 BOTTLE (59228-501-16)
Marketing Start Date	2022-10-18
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL eb5646ac-ad41-231b-e053-2995a90a8b43 Details

ACTIVE INGREDIENTS

Ethyl Alcohol 66.5%

PURPOSE

Antiseptic

USES

for handwashing to decrease bacteria on skin without soap and water
recommended for repeated use

WARNINGS

For external use only

Flammable. Keep away from fire or flame

Do not use in the eyes. If this happens, rinse thoroughly with water.

Stop use and ask a doctor if irritation and redness develop and persists for more than 72 hours.

SPL UNCLASSIFIED SECTION

Keep out of reach of children.

If ingested get medical help or contact a Poison Control Center right away.

DIRECTIONS

wet hands and wrists thoroughly with product
allow to dry without wiping
children under 6 should be supervised while using this product

INACTIVE INGREDIENTS

purified water, aloe vera, triethonolamine, carbomer, D&C blue #1, D&C yellow #10, fragrance

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

INSTANT HAND SANITIZER WITH ALOE 66.5% ETHYL ALCOHOL

ethyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:59228-501
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	66.5 mL in 100 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
TROLAMINE (UNII: 9O3K93S3TK)
CARBOMER 940 (UNII: 4Q93RCW27E)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:59228-501-16	473 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/18/2022

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	10/18/2022

Labeler - Ems Acquisition Corp. (048602791)

Registrant - Ems Acquisition Corp. (048602791)

Revised: 11/2022

Document Id: ecfa9109-e93e-ad4e-e053-2a95a90a372b

Set id: eb5646ac-ad41-231b-e053-2995a90a8b43

Version: 2

Effective Time: 20221108