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NDC 59088-0299-08 GenRx Anti-Bacterial Gel 62 mL/100mL Details

GenRx Anti-Bacterial Gel 62 mL/100mL

GenRx Anti-Bacterial Gel is a TOPICAL LIQUID in the HUMAN OTC DRUG category. It is labeled and distributed by PureTek Corporation. The primary component is ALCOHOL.

Product Information

NDC	59088-0299
Product ID	59088-299_e68c450b-96b4-30c0-e053-2995a90a9ed0
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	GenRx Anti-Bacterial Gel
Proprietary Name Suffix	n/a
Non-Proprietary Name	Alcohol
Product Type	HUMAN OTC DRUG
Dosage Form	LIQUID
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 59088-0299-08 (59088029908)

Pricing Information	N/A
NDC Package Code	59088-299-08
Billing NDC	59088029908
Package	118 mL in 1 BOTTLE, PUMP (59088-299-08)
Marketing Start Date	2020-03-18
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL a124e37e-1a44-212a-e053-2995a90a0af0 Details

Active Ingredient

Alcohol 62% (v/v)

Purpose

Antiseptic

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

If irritation or rash appears and lasts.

Keep out of reach of children

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

Directions

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

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

Other information

■ Do not store above 110°F (43°C)

Inactive ingredients

Aloe Barbadensis (aloe vera) Leaf Juice, Aminomethyl Propanol, Butyrospermum Parkii (Shea) Butter, Carbomer, Glycerin, Isopropyl Myristate, Water (Aqua)

GenRx Hand Sanitizing Gel (24 fl oz)

INGREDIENTS AND APPEARANCE

GENRX ANTI-BACTERIAL GEL

alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:59088-299
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)
AMINOMETHYL PROPANEDIOL (UNII: CZ7BU4QZJZ)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
GLYCERIN (UNII: PDC6A3C0OX)
CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
PANTHENOL (UNII: WV9CM0O67Z)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:59088-299-48	710 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	03/18/2020	05/11/2020
2	NDC:59088-299-08	118 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	03/18/2020
3	NDC:59088-299-31	500 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product	03/18/2020
4	NDC:59088-299-39	710 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	03/18/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	03/18/2020

Labeler - PureTek Corporation (785961046)

Name	Address	ID/FEI	Business Operations
Establishment
PureTek Corporation		785961046	manufacture(59088-299)

Revised: 8/2022

Document Id: e68c450b-96b4-30c0-e053-2995a90a9ed0

Set id: a124e37e-1a44-212a-e053-2995a90a0af0

Version: 5

Effective Time: 20220818