ALTAIO SANITIZING WIPES- alcohol cloth 
BIONATEO SP Z O O

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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The ALTAIO Sanitizing Wipes is a product manufactured using only the following United States Pharmacopoeia (USP) grade ingredients in the preparation of the product:

  1. Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (70%, volume/volume (w/w)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
  2. Glycerin (3% w/w).
  3. Sterile distilled water or boiled cold water.

The firm does not add other active or inactive ingredients. Different or additional ingredients may impact the quality and potency of the product.

Active Ingredient(s)

Ethyl Alcohol 70% w/w. Purpose: Antimicrobial

Purpose

Antimicrobial, Hand Sanitizer, Hard Surface Sanitizer

Use

Hand and hard surface sanitizer to help reduce bacteria that potentially can cause disease.

Warnings

For external use only. Flammable. Keep away from heat or flame

Do not use

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

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.

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.

Directions

Other information

Inactive ingredients

glycerin, purified water USP

Package Label - Principal Display Panel

ALTAIO Sanitizing Wipes 700CT NDC: 78571-004-01

ALTAIO Sanitizing Wipes

ALTAIO SANITIZING WIPES 
alcohol cloth
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78571-004
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX) 3 g  in 100 g
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:78571-004-011300 g in 1 PAIL; Type 0: Not a Combination Product06/24/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A06/24/2020
Labeler - BIONATEO SP Z O O (438233495)
Registrant - BIONATEO SP Z O O (438233495)
Establishment
NameAddressID/FEIBusiness Operations
BIONATEO SP Z O O438233495manufacture(78571-004)

Revised: 6/2020
Document Id: a8731240-9249-de46-e053-2a95a90a34c2
Set id: a8735870-7d13-0a5b-e053-2995a90ad50c
Version: 1
Effective Time: 20200622
 
BIONATEO SP Z O O