STRATON- alcohol aerosol 
Aerosoles Francomexicanos, 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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STRATON DISINFECTANT SPRAY

ACTIVE INGREDIENTS

ACTIVE INGREDIENTS

ETHYL ALCOHOL

CATIONIC SURFACTANT

INACTIVE INGREDIENTS

INACTIVE INGREDIENTS

WATER, ANTIOXIDANT, FRAGRANCE, AND PROPELLANT: N-BUTANE, PROPANE

INDICATIONS AND USAGE

HANDS; SHAKE WELL BEFORE USING.

HOLD CAN VERTICALLY 6 - 8 INCHES FROM THE PALM OF YOUR HANDS AND SPRAY ENOUGH ON THE PALM.

RUB THE PALM OF YOUR HANDS AND FINGERTIPS UNTIL PRODUCT IS COMPLETELY DRY.

DOSAGE AND ADMINISTRATION

SPRAY ENOUGH PRODUCT ON THE PALM TO RUB YOUR HANDS AND FINGERTIPS UNTIL PRODUCT IS COMPLETELY DRY.

WARNINGS AND PRECAUTIONS

DO NOT APPLY NEAR FACE OR EYES

DO NOT ALLOW CHILDREN TO HANDLE THE PRODUCT

DO NOT USE ON CHILDREN UNDER 1 YEAR OLD.

DO NOT BURN OR PUNCTURE THE CONTAINER,

DO NOT USE NEAR THE EYES AND FLAME.

DO NOT EXPOSE TO HEAT, NOR INCINERATE IT.

DO NOT STORE IN TEMPERATURES ABOVE 124° F.

WARNINGS

FLAMMABLE PRODUCT

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN

PURPOSE

ANTIMICROBIAL

DO NOT USE

DO NOT USE ON CHILDREN UNDER 1 YEAR OLD.

ASK A DOCTOR SECTION

EYE CONTACT

INGESTION

INHALATION

IN ANY CASE GET MEDICAL ATTENTION AND SHOW THIS LABEL

PACKAGE LABEL

STRATON DISINFECTANT SPRAY 420 mL

STRATON 
alcohol aerosol
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80105-1000
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.4643 mL  in 1 mL
N-ALKYL ETHYLBENZYL DIMETHYL AMMONIUM CHLORIDE (C12-C14) (UNII: G258TFN61X) (N-ALKYL ETHYLBENZYL DIMETHYL AMMONIUM (C12-C14) - UNII:85440928RV) N-ALKYL ETHYLBENZYL DIMETHYL AMMONIUM CHLORIDE (C12-C14)0.0006 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
BUTANE (UNII: 6LV4FOR43R) 0.2857 mL  in 1 mL
SODIUM NITRATE N-15 (UNII: 0GNX7H7XF7) 0.0019 mL  in 1 mL
WATER (UNII: 059QF0KO0R) 0.1513 mL  in 1 mL
PROPANE (UNII: T75W9911L6) 0.0952 mL  in 1 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:80105-1000-2420 mL in 1 CAN; Type 0: Not a Combination Product09/01/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A09/01/2020
Labeler - Aerosoles Francomexicanos, S.A. de C.V. (951582146)
Registrant - Aerosoles Francomexicanos, S.A. de C.V. (951582146)
Establishment
NameAddressID/FEIBusiness Operations
Aerosoles Francomexicanos, S.A. de C.V.951582146manufacture(80105-1000)

Revised: 1/2022
Document Id: d6adfc1a-d8f3-7559-e053-2995a90a7dcf
Set id: ae4d5ae2-3cb6-7a8e-e053-2a95a90a98d0
Version: 2
Effective Time: 20220128
 
Aerosoles Francomexicanos, S.A. de C.V.