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

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 TypeHUMAN OTC DRUGItem Code (Source)NDC:81576-1000
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.0006 mg  in 1 mL
DIDECYLDIMONIUM CHLORIDE (UNII: JXN40O9Y9B) (DIDECYLDIMONIUM - UNII:Z7F472XQPA) DIDECYLDIMONIUM CHLORIDE0.0018 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:81576-1000-21000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/16/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A02/16/2021
Labeler - PALVI MEXICO, S.A. DE C.V. (824338511)
Registrant - PALVI MEXICO, S.A. DE C.V. (824338511)
Establishment
NameAddressID/FEIBusiness Operations
PALVI MEXICO, S.A. DE C.V.824338511manufacture(81576-1000)

Revised: 2/2021
Document Id: bb808aaa-4eb7-06c3-e053-2995a90a54a4
Set id: bb808aaa-4eb6-06c3-e053-2995a90a54a4
Version: 1
Effective Time: 20210216
 
PALVI MEXICO, S.A. DE C.V.