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NDC 49035-0701-11 Equate Antibacterial Citrus Hand 1.3 mg/mL Details

Equate Antibacterial Citrus Hand 1.3 mg/mL

Equate Antibacterial Citrus Hand is a TOPICAL LIQUID in the HUMAN OTC DRUG category. It is labeled and distributed by Wal-Mart Store Inc. The primary component is BENZALKONIUM CHLORIDE.

Product Information

NDC	49035-0701
Product ID	49035-701_2009f2c8-c730-4308-bd07-aad71e3be8f5
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 Antibacterial Citrus Hand
Proprietary Name Suffix	n/a
Non-Proprietary Name	Benzalkonium Chloride
Product Type	HUMAN OTC DRUG
Dosage Form	LIQUID
Route	TOPICAL
Active Ingredient Strength	1.3
Active Ingredient Units	mg/mL
Substance Name	BENZALKONIUM CHLORIDE
Labeler Name	Wal-Mart Store 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 49035-0701-11 (49035070111)

Pricing Information	N/A
NDC Package Code	49035-701-11
Billing NDC	49035070111
Package	333 mL in 1 BOTTLE, PLASTIC (49035-701-11)
Marketing Start Date	2017-01-05
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL f79329df-361b-4cbf-9865-f5684abf560e Details

Active ingredient

Benzalkonium Chloride 0.13%

Purpose

Antibacterial

Uses

helps eliminate bacteria on hands.

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, get medical help or contact a Poison Control Center immediately.

Directions

apply onto wet hands.
lather and rinse thoroughly.

Other information

store at room temperature.

Inactive ingredients

Water (Aqua), Cetrimonium Chloride, Glycerin, Lauramidopropylamine Oxide, Sodium Chloride, Cocamide MEA, PEG-120 Methyl Glucose Dioleate, Fragrance (Parfum), Citric Acid, Tetrasodium EDTA, Sodium Sulfate, Methylchloroisothiazolinone, Methylisothiazolinone, Citrus Nobilis (Mandarin Orange) Peel Extract, Camellia Sinensis Leaf Extract, Zingiber Officinale (Ginger) Root Extract, Yellow 5 (CI 19140), Blue 1 (CI 42090).

Questions or comments?

1-888-287-1915

Label Copy

INGREDIENTS AND APPEARANCE

EQUATE ANTIBACTERIAL CITRUS HAND

benzalkonium chloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:49035-701
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)
GLYCERIN (UNII: PDC6A3C0OX)
LAURAMIDOPROPYLAMINE OXIDE (UNII: I6KX160QTV)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
COCO MONOETHANOLAMIDE (UNII: C80684146D)
PEG-120 METHYL GLUCOSE DIOLEATE (UNII: YM0K64F20V)
CITRIC ACID ACETATE (UNII: DSO12WL7AU)
EDETATE SODIUM (UNII: MP1J8420LU)
SODIUM SULFATE (UNII: 0YPR65R21J)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
TANGERINE PEEL (UNII: JU3D414057)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
GINGER (UNII: C5529G5JPQ)
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:49035-701-11	333 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/05/2017

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	01/05/2017

Labeler - Wal-Mart Store Inc (051957769)

Registrant - Apollo Health and Beauty Care (201901209)

Name	Address	ID/FEI	Business Operations
Establishment
Apollo Health and Beauty Care		201901209	manufacture(49035-701)

Revised: 1/2017

Document Id: 2009f2c8-c730-4308-bd07-aad71e3be8f5

Set id: f79329df-361b-4cbf-9865-f5684abf560e

Version: 1

Effective Time: 20170106