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NDC 49035-0064-10 Equate Candied Watermelon Antibacterial Hand 1.3 mg/mL Details

Equate Candied Watermelon Antibacterial Hand 1.3 mg/mL

Equate Candied Watermelon Antibacterial Hand is a TOPICAL SOAP in the HUMAN OTC DRUG category. It is labeled and distributed by Wal-Mart Stores Inc. The primary component is BENZALKONIUM CHLORIDE.

Product Information

NDC	49035-0064
Product ID	49035-064_45f95327-3908-4a22-8af8-16c9593a80ad
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	Equate Candied Watermelon Antibacterial Hand
Proprietary Name Suffix	With Moisturizer
Non-Proprietary Name	Benzalkonium Chloride
Product Type	HUMAN OTC DRUG
Dosage Form	SOAP
Route	TOPICAL
Active Ingredient Strength	1.3
Active Ingredient Units	mg/mL
Substance Name	BENZALKONIUM CHLORIDE
Labeler Name	Wal-Mart Stores Inc
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part333E
Listing Certified Through	2022-12-31

Package

Package Images

NDC 49035-0064-10 (49035006410)

Pricing Information	N/A
NDC Package Code	49035-064-10
Billing NDC	49035006410
Package	277 mL in 1 BOTTLE, PLASTIC (49035-064-10)
Marketing Start Date	2018-04-11
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 25c11411-d30c-450a-ab78-b5a8624d7c7a Details

Active ingredient

Benzalkonium Chloride 0.13%

Purpose

Antibacterial

Use

for handwashing to decrease bacteria on the skin.

Warnings

For external use only.

When using this product

avoid contact with eyes. In case of contact, rinse thoroughly with water.

Stop use and ask a doctor if

irritation or redness develops and lasts.

Keep out of reach of children.

In case of accidental ingestion, gem medical help or contact a Poison Control Center immediately.

Directions

apply onto dry hands.
lather and rinse thoroughly.

Other information

store at room temperature.

Inactive ingredients

Water (Aqua), Cetrimonium Chloride, Lauramidopropylamine Oxide, Glycerin, Lauramine Oxide, Sodium Chloride, Cocamide MEA, PEG-120 Methyl Glucose Dioleate, Fragrance (Parfum), Citric Acid, Tetrasodium EDTA, Sodium Benzoate, Red 40 (CI 16035), Yellow 5 (CI 19140), Red 33 (CI 17200).

Label Copy

INGREDIENTS AND APPEARANCE

EQUATE CANDIED WATERMELON ANTIBACTERIAL HAND WITH MOISTURIZER

benzalkonium chloride soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:49035-064
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	1.3 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP)
LAURAMIDOPROPYLAMINE OXIDE (UNII: I6KX160QTV)
GLYCERIN (UNII: PDC6A3C0OX)
LAURAMINE OXIDE (UNII: 4F6FC4MI8W)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
COCO MONOETHANOLAMIDE (UNII: C80684146D)
PEG-120 METHYL GLUCOSE DIOLEATE (UNII: YM0K64F20V)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
EDETATE SODIUM (UNII: MP1J8420LU)
SODIUM BENZOATE (UNII: OJ245FE5EU)
FD&C RED NO. 40 (UNII: WZB9127XOA)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:49035-064-10	277 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/11/2018

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	04/11/2018

Labeler - Wal-Mart Stores Inc (051957769)

Registrant - Apollo Health and Beauty Care Inc. (201901209)

Name	Address	ID/FEI	Business Operations
Establishment
Apollo Health and Beauty Care Inc.		201901209	manufacture(49035-064)

Revised: 4/2018

Document Id: 45f95327-3908-4a22-8af8-16c9593a80ad

Set id: 25c11411-d30c-450a-ab78-b5a8624d7c7a

Version: 2

Effective Time: 20180412