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NDC 70415-0503-01 DELICARE NON-ALCOHOL HAND SANITIZER 0.13 g/100mL Details

DELICARE NON-ALCOHOL HAND SANITIZER 0.13 g/100mL

DELICARE NON-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 BENZALKONIUM CHLORIDE.

Product Information

NDC	70415-0503
Product ID	70415-503_d4b7f928-fe2c-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	DELICARE NON-ALCOHOL HAND SANITIZER
Proprietary Name Suffix	n/a
Non-Proprietary Name	Benzalkonium Chloride
Product Type	HUMAN OTC DRUG
Dosage Form	SOLUTION
Route	TOPICAL
Active Ingredient Strength	0.13
Active Ingredient Units	g/100mL
Substance Name	BENZALKONIUM CHLORIDE
Labeler Name	CWGC LA Inc.
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part333E
Listing Certified Through	2023-12-31

Package

Package Images

NDC 70415-0503-01 (70415050301)

Pricing Information	N/A
NDC Package Code	70415-503-01
Billing NDC	70415050301
Package	1000 mL in 1 BOTTLE (70415-503-01)
Marketing Start Date	2020-12-21
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL d4fa36ed-a331-4f47-a038-87085da8aaf7 Details

Active ingredient

BENZALKONIUM CHLORIDE 0.13%

Purpose

Antibacterial

Uses

FOR SANITIZING TO REDUCE BACTERIA ON THE SKIN

Warnings

For external use only

WHEN USING THIS PRODUCT

Avoid contact with eyes. In case of eye contact, flush eyes 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, PROPYLENE GLYCOL, COCAMIDOPROPYL BETAINE, COCAMINE OXIDE, DISODIUM EDTA, DMDM HYDANTOIN, TRIETHANOLAMINE, FRAGRANCE, FD&C YELLOW NO. 5, FD&C BLUE NO. 1

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

DELICARE NON-ALCOHOL HAND SANITIZER

benzalkonium chloride solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:70415-503
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.13 g in 100 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
COCAMINE OXIDE (UNII: QWA2IZI6FI)
EDETATE DISODIUM (UNII: 7FLD91C86K)
DMDM HYDANTOIN (UNII: BYR0546TOW)
TROLAMINE (UNII: 9O3K93S3TK)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:70415-503-01	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	part333E	12/21/2020

Labeler - CWGC LA Inc. (034967904)

Revised: 1/2022

Document Id: d4b7f928-fe2c-e302-e053-2995a90a52c4

Set id: d4fa36ed-a331-4f47-a038-87085da8aaf7

Version: 3

Effective Time: 20220103