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NDC 49035-0036-07 Equate Foaming Hand Wash 1.3 mg/mL Details

Equate Foaming Hand Wash 1.3 mg/mL

Equate Foaming Hand Wash 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	49035-0036
Product ID	49035-036_b70dd39c-b628-4799-81bc-6fb02634493f
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 Foaming Hand Wash
Proprietary Name Suffix	Energy Berry
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 49035-0036-07 (49035003607)

Pricing Information	N/A
NDC Package Code	49035-036-07
Billing NDC	49035003607
Package	222 mL in 1 BOTTLE, PLASTIC (49035-036-07)
Marketing Start Date	2016-08-21
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 9d7e02a9-e712-4bf7-b591-4e2b9f57ac53 Details

Active ingredient

Benzalkonium chloride 0.13%

Purpose

Antibacterial

Use

for handwashing to decrease bacteria on the skin.

Warnings

For external use only: hands only

When using this product

avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.

Stop use and ask a doctor if

irritation or redness develops.
condition persists for more than 72 hours.

Keep out of reach of children.

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

Directions

wet hands
apply palmful to hands
scrub and rinse thoroughly

Inactive ingredients

Water (Aqua), Cocamidopropyl Betaine, Polysorbate 20, Fragrance (Parfum), Glycerin, Decyl Glucoside, Aloe Barbadensis Leaf Juice, Camellia Sinensis Leaf Extact, Polyquaternium-7, Xanthan Gum, Tetrasodium EDTA, Sodium Citrate, Citric Acid, Benzophenone-4, Methylchloroisothiazolinone, Methylisothiazolinone, Red 33 (CI 17200), Yellow 5 (CI 19140).

Questions?

Call 1-888-287-1915

Label copy

INGREDIENTS AND APPEARANCE

EQUATE FOAMING HAND WASH ENERGY BERRY

benzalkonium chloride soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:49035-036
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)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
GLYCERIN (UNII: PDC6A3C0OX)
DECYL GLUCOSIDE (UNII: Z17H97EA6Y)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600000 MW) (UNII: 0L414VCS5Y)
XANTHAN GUM (UNII: TTV12P4NEE)
EDETATE SODIUM (UNII: MP1J8420LU)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
SULISOBENZONE (UNII: 1W6L629B4K)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:49035-036-07	222 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/21/2016

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	08/21/2016

Labeler - Wal-mart Stores Inc (051957769)

Registrant - Apollo Health and Beauty Care (201901209)

Name	Address	ID/FEI	Business Operations
Establishment
Apollo Health and Beauty Care		201901209	manufacture(49035-036)

Revised: 8/2016

Document Id: b70dd39c-b628-4799-81bc-6fb02634493f

Set id: 9d7e02a9-e712-4bf7-b591-4e2b9f57ac53

Version: 1

Effective Time: 20160822