FRESHQUITAS ANTISEPTIC HAND WIPES- alcohol cloth

Freshquitas Antiseptic Hand Wipes by

Drug Labeling and Warnings

Freshquitas Antiseptic Hand Wipes by is a Otc medication manufactured, distributed, or labeled by Carmel Industria e Comercio de Produtos de Higiene e Limpeza Ltda. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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

• For hand washing to decrease bacteria on the skin disease
• Recommended for repeated use

Warnings

For external use only.

Flammable. Keep away from fire or flame.

Allergy Alert: Contains Almond Oil.

WHEN USING

When using this product:

• avoid contact with eyes, ears, and mouth. If contact occurs with eyes, flush thoroughly with water
• avoid contact with broken skin
• avoid inhalation
• if inhaled for prolonged period, seek immediate medical attention

STOP USE

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

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

Do not use

• in children less than 2 months of age
• if you are allergic to any ingredients
• on open skin wounds

Directions

• Remove wet wipe and apply thoroughly to hands as desired
• Allow to dry without wiping
• Supervise children in the use of this product
• Use only as directed.

Other information

• Store between 59-86°F
• Keep sealed after between uses
• Avoid freezing and heat above 104°F
• May discolor certain fabrics or surfaces

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

40 Wipes NDC: 79089-501-02

150 Wipes NDC: 79089-501-03

INGREDIENTS AND APPEARANCE

FRESHQUITAS ANTISEPTIC HAND WIPES 
alcohol cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79089-501
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	70 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79089-501-01	10 in 1 PACKAGE	03/01/2021
1		32 mL in 1 PACKAGE; Type 0: Not a Combination Product
2	NDC: 79089-501-02	40 in 1 PACKAGE	03/01/2021
2		110 mL in 1 PACKAGE; Type 0: Not a Combination Product
3	NDC: 79089-501-03	150 in 1 PACKAGE	03/01/2021
3		411 mL in 1 CANISTER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	03/01/2021

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
Name	Address	ID/FEI	Business Operations
Carmel Industria e Comercio de Produtos de Higiene e Limpeza Ltda		903638113	manufacture(79089-501)