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NDC 70415-0601-11 ALCOHOL HAND SANITIZER 70 mL/100mL Details

ALCOHOL HAND SANITIZER 70 mL/100mL

ALCOHOL HAND SANITIZER is a TOPICAL SOLUTION in the HUMAN OTC DRUG category. It is labeled and distributed by CWGC LA Inc.. The primary component is ALCOHOL.

Product Information

NDC	70415-0601
Product ID	70415-601_d4b7f928-fe21-e302-e053-2995a90a52c4
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	ALCOHOL HAND SANITIZER
Proprietary Name Suffix	n/a
Non-Proprietary Name	ETHYL ALCOHOL
Product Type	HUMAN OTC DRUG
Dosage Form	SOLUTION
Route	TOPICAL
Active Ingredient Strength	70
Active Ingredient Units	mL/100mL
Substance Name	ALCOHOL
Labeler Name	CWGC LA 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 70415-0601-11 (70415060111)

Pricing Information	N/A
NDC Package Code	70415-601-11
Billing NDC	70415060111
Package	1000 mL in 1 BOTTLE (70415-601-11)
Marketing Start Date	2020-12-21
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL b8735594-5437-40cf-a552-bcddc94a9c80 Details

Active ingredient

Ethyl Alcohol 70 %

PURPOSE

ANTIBACTERIAL

Uses

FOR SANITIZING TO REDUCE BACTERIA ON THE SKIN.

Warnings

FOR EXTERNAL USE ONLY

FLAMMABLE : KEEP AWAY FROM FIRE OR FLAME

WHEN USING THIS PRODUCT

AVOID CONTACT WITH EYES, IN CASE OF EYE CONTACT, FLUSH WITH WATER.

SPL UNCLASSIFIED SECTION

KEEP OUT OF REACH OF CHILDREN. IF SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

Directions

APPLY ONE SHOT OF FOAMING SANITIZER TO DRY HANDS
RUB INTO SKIN
NO RINSING REQUIRED

Inactive ingredients

WATER, ISOPROPYL ALCOHOL, PROPYLENE GLYCOL, PEG-12 DIMETHICONE CROSSPOLYMER, BIS-PEG-12 DIMETHICONE

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ALCOHOL HAND SANITIZER

ethyl alcohol solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:70415-601
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
WATER (UNII: 059QF0KO0R)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PEG-12 DIMETHICONE (300 CST) (UNII: ZEL54N6W95)
BIS-PEG-12 DIMETHICONE (70 MPA.S) (UNII: 2JDK5W22H4)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:70415-601-11	1000 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/21/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	12/21/2020

Labeler - CWGC LA Inc. (034967904)

Revised: 1/2022

Document Id: d4b7f928-fe21-e302-e053-2995a90a52c4

Set id: b8735594-5437-40cf-a552-bcddc94a9c80

Version: 4

Effective Time: 20220103