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NDC 52305-0001-01 Ethyl Alcohol 70 mL/100mL Details

Ethyl Alcohol 70 mL/100mL

Ethyl Alcohol is a TOPICAL GEL in the HUMAN OTC DRUG category. It is labeled and distributed by Freshorize Ltd. The primary component is ALCOHOL.

Product Information

NDC	52305-0001
Product ID	52305-001_ea25b561-b90f-bf8c-e053-2a95a90a2c88
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	Ethyl Alcohol
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	Freshorize Ltd
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part333A
Listing Certified Through	n/a

Package

Package Images

NDC 52305-0001-01 (52305000101)

Pricing Information	N/A
NDC Package Code	52305-001-01
Billing NDC	52305000101
Package	60 mL in 1 BOTTLE, PUMP (52305-001-01)
Marketing Start Date	2020-06-15
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL a7ac0e16-d13a-b55e-e053-2a95a90a0f39 Details

Inactive Ingredients

Water (Aqua), Glycerin, Carbomer, Triethanolamine, Propylene Glycol, Tocopheryl, Aloe Barbadensis Leaf Juice.

Directions

Wet hands thoroughly with product

Briskly rub hands together until dry

supervise children under 6 years in the use of this product

Warnings

For external use only.

Flammable, keep away from fire and flame.

Do not use in the eyes. In case of contact, rinse eyes throughly with water.

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

Warnings

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

Active Ingredient

Ethyl Alcohol 70% v/v

Other Information

Store at 20ºC to 25ºC (68º to 77ºF)

May discolour certain fabrics

Purpose

Antimicrobial

Uses

For handwashing to decrease bacteria on the skin.

Recommended for repeated use.

SPL UNCLASSIFIED SECTION

There are no specific directions. It is a hand sanitizer with the directions for use to just add to your hand and briskly rub until dry.

Typical use would be one pump.

Label

Package Label

Alcohol Hand Sanitizer

INGREDIENTS AND APPEARANCE

ETHYL ALCOHOL

alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:52305-001
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
CARBOMER 934 (UNII: Z135WT9208)	0.28 mL in 100 mL
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)	0.001 mL in 100 mL
WATER (UNII: 059QF0KO0R)	37.307 mL in 100 mL
GLYCERIN (UNII: PDC6A3C0OX)	0.3 mL in 100 mL
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)	0.001 mL in 100 mL
ALOE VERA LEAF (UNII: ZY81Z83H0X)	0.001 mL in 100 mL

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:52305-001-01	60 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	06/15/2020	12/31/2023
2	NDC:52305-001-02	236 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	06/15/2020	12/31/2023
3	NDC:52305-001-03	296 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	06/15/2020	12/31/2023
4	NDC:52305-001-04	500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	06/15/2020	12/31/2023

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	06/15/2020	12/31/2023

Labeler - Freshorize Ltd (424168503)

Registrant - Freshorize USA LLC (078206924)

Revised: 10/2022

Document Id: ea25b561-b90f-bf8c-e053-2a95a90a2c88

Set id: a7ac0e16-d13a-b55e-e053-2a95a90a0f39

Version: 4

Effective Time: 20221003

Search by Drug Name or NDC

NDC 52305-0001-01 Ethyl Alcohol 70 mL/100mL Details

Ethyl Alcohol 70 mL/100mL

Product Information

Package

Package Images

NDC 52305-0001-01 (52305000101)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL a7ac0e16-d13a-b55e-e053-2a95a90a0f39 Details

Inactive Ingredients

Directions

Warnings

Warnings

Active Ingredient

Other Information

Purpose

Uses

SPL UNCLASSIFIED SECTION

Label

Package Label

INGREDIENTS AND APPEARANCE

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