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NDC 49035-0059-08 Equate Hand Sanitizer 650 mg/mL Details

Equate Hand Sanitizer 650 mg/mL

Equate Hand Sanitizer is a TOPICAL GEL in the HUMAN OTC DRUG category. It is labeled and distributed by Wal-Mart Store Inc. The primary component is ALCOHOL.

Product Information

NDC	49035-0059
Product ID	49035-059_6242c677-c0a8-4463-9129-fab3a7674339
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 Hand Sanitizer
Proprietary Name Suffix	n/a
Non-Proprietary Name	Ethyl Alcohol
Product Type	HUMAN OTC DRUG
Dosage Form	GEL
Route	TOPICAL
Active Ingredient Strength	650
Active Ingredient Units	mg/mL
Substance Name	ALCOHOL
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 49035-0059-08 (49035005908)

Pricing Information	N/A
NDC Package Code	49035-059-08
Billing NDC	49035005908
Package	236 mL in 1 BOTTLE, PLASTIC (49035-059-08)
Marketing Start Date	2017-06-13
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 8709cfbe-221b-4e3a-9acf-37dc45cc53e1 Details

Active ingredient

Ethyl Alcohol 65%

Purpose

Antiseptic

Uses

to help reduce bacteria on the skin.

Warnings

For external use only

flammable
keep away from source of heat or fire

When using this product

avoid contact with eyes. If contact ocdcurs, 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

put enough product in your palm to cover hands and rub hands together until dry.
children under 6 years should be supervised when using this product.

Other information

store at a temperature below 110°F (43°C)
may discolor certain fabrics or surfaces

Inactive ingredients

Water (Aqua), Isopropyl Alcohol, Glycerin, Isopropyl Myristate, Aloe Barbadensis Leaf Juice, Tocopheryl Acetate, Carbomer, Aminomethyl Propanol, Fragrance (Parfum).

Questions or comments?

1-888-287-1915

Label Copy

INGREDIENTS AND APPEARANCE

EQUATE HAND SANITIZER

ethyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:49035-059
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	650 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
GLYCERIN (UNII: PDC6A3C0OX)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
CARBOMER 934 (UNII: Z135WT9208)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:49035-059-08	236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/13/2017

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	06/13/2017

Labeler - Wal-Mart Store 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(49035-059)

Revised: 6/2017

Document Id: 6242c677-c0a8-4463-9129-fab3a7674339

Set id: 8709cfbe-221b-4e3a-9acf-37dc45cc53e1

Version: 1

Effective Time: 20170614