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NDC 81524-0111-01 Premium Hand Sanitizer Gel 70 mL/100mL Details

Premium Hand Sanitizer Gel 70 mL/100mL

Premium Hand Sanitizer Gel is a TOPICAL GEL in the HUMAN OTC DRUG category. It is labeled and distributed by SOOTSOAP SUPPLY CO LTD. The primary component is ALCOHOL.

Product Information

NDC	81524-0111
Product ID	81524-111_d70cde43-be9d-56fb-e053-2a95a90a3c4f
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	Premium Hand Sanitizer Gel
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	SOOTSOAP SUPPLY 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 81524-0111-01 (81524011101)

Pricing Information	N/A
NDC Package Code	81524-111-01
Billing NDC	81524011101
Package	5 mL in 1 BOTTLE (81524-111-01)
Marketing Start Date	2021-02-12
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL bb144885-fad6-3699-e053-2995a90aa51d Details

Directions

- Place enough product on hands to cover all surfaces. Rub hands together until dry.

- Supervise children under 6 years of age when using this product to avoid swallowing.

Inactive Ingredients

Purified water, Aloe Barbadensis Leaf Juice Powder, Hydroxyethyl cellulose, Mentha Piperita (Peppermint) Essential Oil

Uses

Hand Sanitizer to help reduce bacteria that potentially can cause disease.

For use when soap and water are not available.

Keep out of reach of children.

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

Purpose

Antiseptic

Active Ingredient[s]

Alcohol (Ethanol) 70% v/v

Warnings

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

- Do not use in children less than 2 months of age. Do not use in open skin wounds.

- When using this product keep out of eyes, ears and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

PREMIUM HAND SANITIZER GEL

alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:81524-111
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
ALOE VERA LEAF (UNII: ZY81Z83H0X)
HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)
WATER (UNII: 059QF0KO0R)
PEPPERMINT OIL (UNII: AV092KU4JH)

Product Characteristics
Color	gray (Clear)	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:81524-111-01	5 mL in 1 BOTTLE; Type 0: Not a Combination Product	02/12/2021
2	NDC:81524-111-04	60 mL in 1 BOTTLE; Type 0: Not a Combination Product	02/12/2021
3	NDC:81524-111-07	473 mL in 1 BOTTLE; Type 0: Not a Combination Product	02/12/2021

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	02/12/2021

Labeler - SOOTSOAP SUPPLY CO LTD (204255801)

Registrant - SOOTSOAP SUPPLY CO LTD (204255801)

Name	Address	ID/FEI	Business Operations
Establishment
Natures Formulae Health Products Ltd.		241385587	manufacture(81524-111)

Revised: 1/2022

Document Id: d70cde43-be9d-56fb-e053-2a95a90a3c4f

Set id: bb144885-fad6-3699-e053-2995a90aa51d

Version: 2

Effective Time: 20220101