ASSURED- benzalkonium chloride swab 
INDELPA, 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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Benzalkonium Chloride 0.125%

Antibacterial

USE

Decreases bacteria on skin.


For external use only

If you are allergic to any of the ingredients

Do not get into eyes.

If contact occurs, rinse thoroughly with water.

If irritation or rash develops and continues for more than 72 hours

If irritation or rash develops and continues for more than 72 hours

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

  • Thoroughly wipe hands and face as desired.

  • Allow to dry without wiping.
  • Discard wipe in trash receptacle after use.
  • Do not flush.

To dispense wipe: Peel back front label slowly. Remove wipes.

To reseal pouch: Firmly run thumb over the label.

Store at room temperature. Cold weather may cloud this product. It's antiseptic properties are not affected.

Water, Propylene Glycol, Polysorbate 20, Sodium Cocoamphoacetate, Fragrance, Citric Acid, Vitamin E, Methylchloroisothiazolinone, Aloe Extract, Tetrasodium EDTA.

Dosage: Swab

Administration: Topical

Assured TM Antibacterial Wet Wipes kills germs and bacteria, cleans and freshens your skin and gently wipes away perspiration and odor.

With moisturizing formula containing Aloe Vera and Vitamin E, Assured TM Antibacterial Wet Wipes are soft and gentle, and helping to nourish your skin as you freshen up.

This travel pack is convenitent to take along for use anytime or anywhere.

ASSURED
Antibacterial
Wet Wipes
Hand & face moisturizing towelettes

For hands and face
Ideal for travling
Moisturizing
Thick and soft cloths
Fresh scent

LABEL WATERFALLWATERFALLASSURED ANTIBACTERIAL WIPES 3X10

ANTIBACTERIAL 15 COUNT

INNER ANIBACTERIAL 15 COUNT

ANTIBACTERIAL 20 COUNT

ANTIBACTERIAL 40 COUNT

ASSURED 
benzalkonium chloride swab
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70697-800
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.125 mg  in 100 mg
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R) 98.54 mg  in 100 mg
ALOE VERA LEAF (UNII: ZY81Z83H0X) 0.05 mg  in 100 mg
POLYSORBATE 20 (UNII: 7T1F30V5YH) 0.3 mg  in 100 mg
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) 0.01 mg  in 100 mg
PROPYLENE GLYCOL (UNII: 6DC9Q167V3) 0.5 mg  in 100 mg
SODIUM COCOAMPHOACETATE (UNII: W7Q5E87674) 0.2 mg  in 100 mg
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN) 0.1 mg  in 100 mg
EDETATE SODIUM (UNII: MP1J8420LU) 0.03 mg  in 100 mg
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) 0.018 mg  in 100 mg
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70697-800-033 in 1 BAG06/10/2016
110 in 1 PACKAGE
13 mg in 1 POUCH; Type 0: Not a Combination Product
2NDC:70697-800-0440 in 1 PACKAGE06/10/2016
20.375 mg in 1 POUCH; Type 0: Not a Combination Product
3NDC:70697-800-0520 in 1 PACKAGE06/10/2016
30.375 mg in 1 POUCH; Type 0: Not a Combination Product
4NDC:70697-800-062 in 1 PACKAGE06/10/2016
415 in 1 PACKAGE
42 mg in 1 POUCH; Type 0: Not a Combination Product
5NDC:70697-800-0712 in 1 CASE06/10/2016
5103.2 mg in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E06/10/2016
Labeler - INDELPA, S.A. DE C.V. (811072487)
Registrant - INDELPA, S.A. DE C.V. (811072487)
Establishment
NameAddressID/FEIBusiness Operations
INDELPA, S.A. DE C.V.811072487manufacture(70697-800) , analysis(70697-800) , pack(70697-800) , label(70697-800)

Revised: 1/2022
Document Id: d57bb3c4-9079-5727-e053-2995a90a8f94
Set id: 317f63af-9696-6bef-e054-00144ff8d46c
Version: 8
Effective Time: 20220113
 
INDELPA, S.A. DE C.V.