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NDC 66777-0001-01 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 West Coast Cosmetics, Inc.. The primary component is ISOPROPYL ALCOHOL.

Product Information

NDC	66777-0001
Product ID	66777-001_a619b846-b033-1cbb-e053-2995a90ace50
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	ISOPROPYL ALCOHOL
Product Type	HUMAN OTC DRUG
Dosage Form	GEL
Route	TOPICAL
Active Ingredient Strength	70
Active Ingredient Units	mL/100mL
Substance Name	ISOPROPYL ALCOHOL
Labeler Name	West Coast Cosmetics, Inc.
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 66777-0001-01 (66777000101)

Pricing Information	N/A
NDC Package Code	66777-001-01
Billing NDC	66777000101
Package	3780 mL in 1 JUG (66777-001-01)
Marketing Start Date	2020-06-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL a5f1d564-6c6b-1d93-e053-2a95a90a45d4 Details

Drug Facts

Active ingredients

Isopropyl 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

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

When using this product

keep out of eyes, ears and mouth. In case of contact with eyes, rinse thoroughly with water.

Stop use and ask a doctor if

if irritation or rash occurs. These may be signs of a serious condition.

Keep out of reach of children.

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

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.

Other information

Store between 15-30C (59-86F).
Avoid freezing and excessive heat above 40C (104F).
You may report a seious adverse reaction to West Coast Cosmetics 21050 Superior Street, Chatsworth, CA 91311

Inactive ingredients

Aloe Barbadensis Leaf Juice, Carbomer, Glycerin, Purified Water USP, Triisopropanolamine

Product Packaging - 3.78 L

WEST COAST

Cosmetics, Inc.

Isopropyl Alcohol Antiseptic 70%

Topical Solution

Hand Sanitizer Gel

Non-sterile Solution

1 Gallon (3.78L)

INGREDIENTS AND APPEARANCE

HAND SANITIZER

isopropyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:66777-001
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302)	ISOPROPYL ALCOHOL	70 mL in 100 mL

Ingredient Name	Strength
Inactive Ingredients
GLYCERIN (UNII: PDC6A3C0OX)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
TRIISOPROPANOLAMINE (UNII: W9EN9DLM98)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:66777-001-01	3780 mL in 1 JUG; Type 0: Not a Combination Product	06/01/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	06/01/2020

Labeler - West Coast Cosmetics, Inc. (967468158)

Revised: 5/2020

Document Id: a619b846-b033-1cbb-e053-2995a90ace50

Set id: a5f1d564-6c6b-1d93-e053-2a95a90a45d4

Version: 2

Effective Time: 20200520