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NDC 59088-0413-36 Hand Sanitizing with Lavender Oil 62 mL/100mL Details

Hand Sanitizing with Lavender Oil 62 mL/100mL

Hand Sanitizing with Lavender Oil is a TOPICAL GEL in the HUMAN OTC DRUG category. It is labeled and distributed by PureTek Corporation. The primary component is ALCOHOL.

Product Information

NDC	59088-0413
Product ID	59088-413_a75d25a7-1e23-717f-e053-2a95a90a6d93
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	Hand Sanitizing with Lavender Oil
Proprietary Name Suffix	n/a
Non-Proprietary Name	Alcohol
Product Type	HUMAN OTC DRUG
Dosage Form	GEL
Route	TOPICAL
Active Ingredient Strength	62
Active Ingredient Units	mL/100mL
Substance Name	ALCOHOL
Labeler Name	PureTek Corporation
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part333A
Listing Certified Through	2024-12-31

Package

Package Images

NDC 59088-0413-36 (59088041336)

Pricing Information	N/A
NDC Package Code	59088-413-36
Billing NDC	59088041336
Package	1 KIT in 1 KIT (59088-413-36) / 1 BOTTLE in 1 KIT (59088-413-14) / 118 mL in 1 BOTTLE (59088-413-08)
Marketing Start Date	2020-06-05
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL a75d25a7-1e23-717f-e053-2a95a90a6d93 Details

Active Ingredient

Alcohol 62% (v/v)

Purpose

Anti-Bacterial

Uses

■ Hand sanitizer to help reduce bacteria on the skin

Warnings

■ Flammable. Keep away from fire or flame.

When using this product

■ do not use in or near eyes. In case of contact, rinse eyes throughly with water

Stop use and ask a doctor if

■ irritation or redness develop and last for more than 72 hours

Keep out of reach of children

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

Directions

■ Dispense and rub onto hands until dry. Do not rinse off.

■ Children under 6 years of age should use this product under supervision.

■ repeat as necessary

Other information

■ Do not store above 110°F (43°C)

Inactive ingredients

Aloe Barbadensis (aloe vera) Leaf Juice, Butyrospermum Parkii (Shea) Butter, Glycerin, Lavandula Angustifolia (Lavender) Oil, Panthenol, Polyacrylate Crosspolymer-6, Water (Aqua)

GenRx Hand Sanitizing Gel with Lavender

Manufactured in the USA by PureTek Corporation

Panorama City, CA 91402 USA

877-921-7873

www.genrxwoundcare.com

List No:41431JLA

NDC 59088-413-08

NDC 59088-413-31

NDC 59088-413-39

INGREDIENTS AND APPEARANCE

HAND SANITIZING WITH LAVENDER OIL

alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:59088-413
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	62 mL in 100 mL

Ingredient Name	Strength
Inactive Ingredients
SHEA BUTTER (UNII: K49155WL9Y)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
GLYCERIN (UNII: PDC6A3C0OX)
PANTHENOL (UNII: WV9CM0O67Z)
WATER (UNII: 059QF0KO0R)
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (4500 MPA.S) (UNII: T967IEU43C)
LAVANDULA ANGUSTIFOLIA FLOWERING TOP (UNII: 9YT4B71U8P)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:59088-413-06	1 in 1 KIT	06/05/2020
1	NDC:59088-413-39	710 mL in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC:59088-413-36	1 in 1 KIT	06/05/2020
2	NDC:59088-413-14	1 in 1 KIT
2	NDC:59088-413-08	118 mL in 1 BOTTLE; Type 0: Not a Combination Product
3	NDC:59088-413-31	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/05/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	06/05/2020

Labeler - PureTek Corporation (785961046)

Name	Address	ID/FEI	Business Operations
Establishment
PureTek Corporation		785961046	manufacture(59088-413) , label(59088-413)

Revised: 6/2020

Document Id: a75d25a7-1e23-717f-e053-2a95a90a6d93

Set id: a75d25a7-1e23-717f-e053-2a95a90a6d93

Version: 1

Effective Time: 20200605