FRESHQUITAS ANTISEPTIC HAND WIPES- alcohol cloth 
Carmel Industria e Comercio de Produtos de Higiene e Limpeza Ltda

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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This is a package of hand sanitizer wipes containing the following ingredients:

  1. Alcohol (ethanol) (70% volume/volume (v/v)).
  2. Aqua
  3. Propylene Glycol,
  4. Phenoxyethanol, PEG-40
  5. Hydrogenated Castor Oil
  6. PEG-12 Dimethicone
  7. Prunus Amygdalus Dulcis (Sweet Almond) Oil
  8. Edetate Disodium

The firm does not add other active or inactive ingredients.

Active Ingredient(s)

Alcohol 70% v/v. Purpose: Antiseptic

Purpose

Antiseptic Hand Wipes

Use

Warnings

For external use only.

Flammable. Keep away from fire or flame.

Allergy Alert: Contains Almond Oil.

When using this product:

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Do not use

Directions

Other information

Inactive ingredients

Aqua, Propylene Glycol, Phenoxyethanol, PEG-40 Hydrogenated Castor Oil, PEG-12 Dimethicone, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Edetate Disodium

Package Label - Principal Display Panel

10 Wipes NDC: 79089-501-01

Freshquitas 10 Wipes

40 Wipes NDC: 79089-501-02

Freshquitas 40 Wipes

150 Wipes NDC: 79089-501-03

Freshquitas 150 Wipes

FRESHQUITAS ANTISEPTIC HAND WIPES 
alcohol cloth
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79089-501
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
EDETATE DISODIUM (UNII: 7FLD91C86K)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
WATER (UNII: 059QF0KO0R)  
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
PEG-12 DIMETHICONE (UNII: ZEL54N6W95)  
ALMOND OIL (UNII: 66YXD4DKO9)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:79089-501-0110 in 1 PACKAGE03/01/2021
132 mL in 1 PACKAGE; Type 0: Not a Combination Product
2NDC:79089-501-0240 in 1 PACKAGE03/01/2021
2110 mL in 1 PACKAGE; Type 0: Not a Combination Product
3NDC:79089-501-03150 in 1 PACKAGE03/01/2021
3411 mL in 1 CANISTER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E03/01/2021
Labeler - Carmel Industria e Comercio de Produtos de Higiene e Limpeza Ltda (903638113)
Registrant - Carmel Industria e Comercio de Produtos de Higiene e Limpeza Ltda (903638113)
Establishment
NameAddressID/FEIBusiness Operations
Carmel Industria e Comercio de Produtos de Higiene e Limpeza Ltda903638113manufacture(79089-501)

Revised: 2/2021
Document Id: bb152372-d3dd-2ad5-e053-2a95a90ae3ef
Set id: bb151f4d-87e7-0948-e053-2a95a90ab186
Version: 1
Effective Time: 20210211
 
Carmel Industria e Comercio de Produtos de Higiene e Limpeza Ltda