MEDICALLY MINDED- benzalkonium chloride cloth 
BELSKIN S. DE, R.L. 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.

----------

ANTICEPTIC WET WIPES

DOSAGE AND ADMINISTRATION

APPLY TO HANDS

ALLOW TO DRY WITHOUT WIPING

WARNINGS AND PRECAUTIONS

WHEN USING THIS PRODUCT DO NOT GET INTO EYES. IF CONTACT OCCURS, RINSE THOROUGHLY WITH WATER.

CHILDREN UNDER 2 YEARS ASK A DOCTOR BEFORE USE

WARNINGS

FOR EXTERNAL USE ONLY

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN. IF SWALLOWED GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

STOP USE AND ASK A DOCTOR

STOP USE AND ASK A DOCTOR IF IRRITATION OR RASH DEVELOPS AND CONTINUES FOR MORE THAN 72 HOURS.

PURPOSE

ANTIMICROBIAL AGENT

ACTIVE INGREDIENT

BENZALKONIUM CHLORIDE

ETHYL ALCOHOL

INACTIVE INGREDIENT

WATER
ALOE VERA (ALOE BARBADENSIS) LEAF JUICE
ANHYDROUS CITRIC ACID
DIMETHICONE
ETHYLENE DIAMINE TETRAACETIC ACID TETRASODIUM SALT (EDTA-4Na)
HYDANTOINE
POLYSORBATE 20
TOCOPHERYL ACETATE (VITAMIN E)
GLYCERIN
FRAGRANCE
METHYLCHLOROISOTHIAZOLINONE
METHYLISOTHIAZOLINONE

INDICATIONS AND USAGE

APPLY TO HANDS

ALLOW TO DRY WITHOUT WIPING

PACKAGE LABEL

MEDICALLY MINDED ANTISEPTIC WIPES 40

MEDICALLY MINDED 
benzalkonium chloride cloth
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78502-6000
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.25 g  in 100 g
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R) 93.885 g  in 100 g
ALOE VERA LEAF (UNII: ZY81Z83H0X) 0.05 g  in 100 g
GLYCERIN (UNII: PDC6A3C0OX) 0.5 g  in 100 g
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA) 0.1 g  in 100 g
DIMETHICONE (UNII: 92RU3N3Y1O) 0.005 g  in 100 g
EDETATE SODIUM TETRAHYDRATE (UNII: L13NHD21X6) 0.008 g  in 100 g
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN) 0.1 g  in 100 g
HYDANTOIN (UNII: I6208298TA) 0.002 g  in 100 g
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) 0.015 g  in 100 g
POLYSORBATE 20 (UNII: 7T1F30V5YH) 0.005 g  in 100 g
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N) 0.08 g  in 100 g
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:78502-6000-640 g in 1 BAG; Type 0: Not a Combination Product06/28/2020
2NDC:78502-6000-730 g in 1 BAG; Type 0: Not a Combination Product06/28/2020
3NDC:78502-6000-820 g in 1 BAG; Type 0: Not a Combination Product06/28/2020
4NDC:78502-6000-910 g in 1 BAG; Type 0: Not a Combination Product06/28/2020
5NDC:78502-6000-11 g in 1 BAG; Type 0: Not a Combination Product06/28/2020
6NDC:78502-6000-25 g in 1 BAG; Type 0: Not a Combination Product06/28/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A06/28/2020
Labeler - BELSKIN S. DE, R.L. DE C.V (816649743)
Registrant - BELSKIN S. DE, R.L. DE C.V (816649743)
Establishment
NameAddressID/FEIBusiness Operations
BELSKIN S. DE, R.L. DE C.V816649743manufacture(78502-6000)

Revised: 7/2020
Document Id: a99869f8-ab2c-14e3-e053-2995a90a8ebd
Set id: a931336d-d2af-40ac-e053-2995a90a297b
Version: 3
Effective Time: 20200704
 
BELSKIN S. DE, R.L. DE C.V