STERITE PLUS- benzalkonium chloride liquid
PALVI MEXICO, S.A. DE C.V.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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STERITE PLUS SANITIZER

ACTIVE INGREDIENTS

DIDECYLDIMONIUM CHLORIDE

BENZALKONIUM CHLORIDE

OTC PURPOSE SECTION

PURPOSE

ANTIMICROBIAL

INDICATIONS AND USAGE

HAND AND SURGACE DISINFECTANT TO HELP REDUCE BACTERIA THAT POTENTIALLY CAUSE DISEASES

DOSAGE AND ADMINISTRATION

DIRECTIONS SPRAY STERITE NEUTRUM ON 12 TO 16 INCHES OVER HANDS, RUB AND AIR DRY, ON SURFACES APPLYING A FINE MIST, WIPE CLEAN. NO RINSING REQUIRED.

WARNINGS AND PRECAUTIONS SECTION

DO NOT USE ON OPEN WOUNDS ON THE SKIN, EYES OR MUCOUS MEMBRANES

DO NOT USE IN EYES. IF CONTACT OCCURS, FLUSH THE EYES WELL WITH PLENTY OF WATER.

WARNINGS

WARNING FOR EXTERNAL USE ONLY

KEEP OUT OF REACH OF CHILDREN

INACTIVE INGREDIENT SECTION

INACTIVE INGREDIENTS: WATER, N-NONYLPHENOL, EUCALYPTOL, LEMON OIL, DISODIUM EDTA, FD&C GREEN NO.3

PACKAGE LABEL SECTION

STERITE PLUS

STERITE PLUS
benzalkonium chloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:81576-1000
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.0006 mg in 1 mL
DIDECYLDIMONIUM CHLORIDE (UNII: JXN40O9Y9B) (DIDECYLDIMONIUM - UNII:Z7F472XQPA)	DIDECYLDIMONIUM CHLORIDE	0.0018 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
EDETATE DISODIUM (UNII: 7FLD91C86K)	0.0003 mL in 1 mL
N-NONYLPHENOL (MIXED ISOMERS) (UNII: 79F6A2ILP5)	0.007 mL in 1 mL
WATER (UNII: 059QF0KO0R)	0.99 mL in 1 mL
LEMON OIL (UNII: I9GRO824LL)	0.0002 mL in 1 mL
ACID GREEN 50 (UNII: 9B7E8Y9D0X)	0.0001 mL in 1 mL

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:81576-1000-2	1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	02/16/2021

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	02/16/2021

Labeler - PALVI MEXICO, S.A. DE C.V. (824338511)

Registrant - PALVI MEXICO, S.A. DE C.V. (824338511)

Name	Address	ID/FEI	Business Operations
Establishment
PALVI MEXICO, S.A. DE C.V.		824338511	manufacture(81576-1000)