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NDC 70415-0109-50 SANITIZING WET WIPES 0.75 1/1 Details

SANITIZING WET WIPES 0.75 1/1

SANITIZING WET WIPES 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	70415-0109
Product ID	70415-109_d4b86f7f-dd7a-07c5-e053-2995a90af540
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	SANITIZING WET WIPES
Proprietary Name Suffix	75 PERCENT
Non-Proprietary Name	ETHYL ALCOHOL
Product Type	HUMAN OTC DRUG
Dosage Form	SOLUTION
Route	TOPICAL
Active Ingredient Strength	0.75
Active Ingredient Units	1/1
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 70415-0109-50 (70415010950)

Pricing Information	N/A
NDC Package Code	70415-109-50
Billing NDC	70415010950
Package	50 APPLICATOR in 1 POUCH (70415-109-50) / 1 SOLUTION in 1 APPLICATOR
Marketing Start Date	2020-08-15
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 1205e43e-18e8-49e2-9964-9b53eb081021 Details

Active ingredient

Alcohol 75%

PURPOSE

ANTISEPTIC

Uses

FOR HAND WASHING TO DECREASE BACTERIA ON THE SKIN. RECOMMENDED FOR REPEAT USE.

Warnings

FOR EXTERNAL USE ONLY.

KEEP OUT OF REACH OF EYES. IF CONTACT OCCURS, RINSE THOROUGHLY WITH WATER.

DO NOT USE IF YOU ARE ALLERGIC TO ANY OF THE INGREDIENTS.

DISCONTINUE USE IF IRRITATION OR REDNESS DEVELOPS, AND IF CONDITION PERSISTS FOR MORE THAN 72 HOURS CONSULT A PHYSICIAN.

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

SPL UNCLASSIFIED SECTION

KEEP OUT OF REACH OF CHILDREN UNLESS UNDER ADULT SUPERVISION.

IF SWALLOWED, GET MEDICAL HELP, OR CONTACT A POISON CONTROL CENTER IMMEDIATELY.

Directions

OPEN RESEALABLE LABEL AND PULL ONE SHEET FROM PACK. THOROUGHLY CLEAN HANDS OR AFFECTED AREA AND DISCARD IN RECEPTACLE, AND DO NOT FLUSH. ALLOW TO DRY WITHOUT WIPING. BE SURE TO RESEAL LABEL COMPLETE TO RETAIN MOISTURE.

Inactive ingredients

WATER (AQUA), GLYCERINE, ALOE ESSENCE EXTRACT, VITAMIN E, PHENOXYETHANOL, BETAINE, BENZALKONIUM CHLORIDE.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SANITIZING WET WIPES 75 PERCENT

ethyl alcohol solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:70415-109
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	0.75

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
BETAINE (UNII: 3SCV180C9W)
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:70415-109-50	50 in 1 POUCH	08/15/2020
1		1 in 1 APPLICATOR; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	08/15/2020

Labeler - CWGC LA Inc. (034967904)

Name	Address	ID/FEI	Business Operations
Establishment
Fujian Yifa Healthcare Products Co., Ltd.		420510793	manufacture(70415-109)

Revised: 1/2022

Document Id: d4b86f7f-dd7a-07c5-e053-2995a90af540

Set id: 1205e43e-18e8-49e2-9964-9b53eb081021

Version: 6

Effective Time: 20220103