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NDC 70415-0502-01 DELICARE ANTIBACTERIAL HAND 0.5 g/100mL Details

DELICARE ANTIBACTERIAL HAND 0.5 g/100mL

DELICARE ANTIBACTERIAL HAND is a TOPICAL SOAP in the HUMAN OTC DRUG category. It is labeled and distributed by CWGC LA Inc.. The primary component is CHLOROXYLENOL.

Product Information

NDC	70415-0502
Product ID	70415-502_d4b7f2c6-7af8-2583-e053-2995a90aaa6d
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 ANTIBACTERIAL HAND
Proprietary Name Suffix	n/a
Non-Proprietary Name	CHLOROXYLENOL
Product Type	HUMAN OTC DRUG
Dosage Form	SOAP
Route	TOPICAL
Active Ingredient Strength	0.5
Active Ingredient Units	g/100mL
Substance Name	CHLOROXYLENOL
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 70415-0502-01 (70415050201)

Pricing Information	N/A
NDC Package Code	70415-502-01
Billing NDC	70415050201
Package	1000 mL in 1 BOTTLE (70415-502-01)
Marketing Start Date	2020-12-21
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 73be3606-84d1-48d1-a241-9916c06b43f5 Details

Active ingredient

Chloroxylenol, 0.5%

Purpose

Antibacterial

PURPOSE

ANTIBACTERIAL

USES

For handwashing 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 with water

SPL UNCLASSIFIED SECTION

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

DIRECTIONS

Apply foaming cleanser to dry hands
Rub hands together to spread lather
Wash for 15-20 seconds
Rinse & dry hands thoroughly

Inactive ingredients

Water, Sodium Laureth Sulfate, Isopropyl Alcohol, Cocamidopropyl Betaine, Decyl Glucoside, SODIUM C14-16 OLEFIN SULFONATE, Hydrogenated castor Oil, DMDM Hydantoin, Citric Acid, Fragrance, FD&C Blue No.1, FD&C Yellow No.5.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

DELICARE ANTIBACTERIAL HAND

chloroxylenol soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:70415-502(NDC:76591-110)
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q)	CHLOROXYLENOL	0.5 g in 100 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
DECYL GLUCOSIDE (UNII: Z17H97EA6Y)
SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U)
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)
DMDM HYDANTOIN (UNII: BYR0546TOW)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:70415-502-01	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	part333A	12/21/2020

Labeler - CWGC LA Inc. (034967904)

Revised: 1/2022

Document Id: d4b7f2c6-7af8-2583-e053-2995a90aaa6d

Set id: 73be3606-84d1-48d1-a241-9916c06b43f5

Version: 4

Effective Time: 20220103