HAND SANITIZER WIPES- ethyl alcohol cloth 
ORGANIKISIMO SA DE CV

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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HAND SANITIZER WIPES BOTTLE

Active Ingredient(s)

Alcohol 70% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer wipes

Use

Hand Sanitizer wipes to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

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

water,Glycerin, Polyethylene glycol, Isopropyl myristate

Package Label - Principal Display Panel

210 ML NDC 79337-158-01 wipes bottle

HAND SANITIZER WIPES 
ethyl alcohol cloth
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79337-158
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
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) 0.37 mL  in 100 mL
GLYCERIN (UNII: PDC6A3C0OX) 0.68 mL  in 100 mL
WATER (UNII: 059QF0KO0R) 28.46 mL  in 100 mL
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) 0.49 mL  in 100 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:79337-158-01210 mL in 1 BOTTLE; Type 0: Not a Combination Product07/27/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A03/30/2020
Labeler - ORGANIKISIMO SA DE CV (951579669)
Registrant - ORGANIKISIMO SA DE CV (951579669)
Establishment
NameAddressID/FEIBusiness Operations
ORGANIKISIMO SA DE CV951579669manufacture(79337-158)

Revised: 12/2020
Document Id: b5831377-9798-efa2-e053-2995a90a1e24
Set id: ab979f2f-d48b-2801-e053-2995a90ab8d0
Version: 3
Effective Time: 20201202
 
ORGANIKISIMO SA DE CV