HAND SANITIZER- alcohol gel 
Octapod, 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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Active Ingredient(s)

Alcohol 70% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Use

Hand Sanitizer 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, carbomer, triethanolamine.

PDP 60mL NDC:78800-002-01 PDP 60 mLPI 60mL NDC:78800-002-01

PI 60 mLPDP 125 mL NDC:78800-002-02 PDP 25 mLPDP 250 mL NDC:78800-002-03 PDP 250 mLPDP 500mL NDC:78800-002-04 PDP 500 mLPDP 1000mL NDC:78800-002-05 PDP 1000 mLPDP 3785 mL NDC:78800-002-06 PDP 3785 mL

HAND SANITIZER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78800-002
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
GLYCERIN (UNII: PDC6A3C0OX) 1.005 mL  in 100 mL
CARBOMER 1342 (UNII: 809Y72KV36) 0.58 mL  in 100 mL
WATER (UNII: 059QF0KO0R)  
TRIETHANOLAMINE HYDRIODIDE (UNII: DT98IT03JK) 0.06 mL  in 100 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:78800-002-0160 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
2NDC:78800-002-02125 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
3NDC:78800-002-03250 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
4NDC:78800-002-04500 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
5NDC:78800-002-051000 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
6NDC:78800-002-063785 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A03/30/2020
Labeler - Octapod, S.A de C.V. (951578993)
Registrant - Octapod, S.A de C.V. (951578993)
Establishment
NameAddressID/FEIBusiness Operations
Octapod, S.A de C.V.951578993manufacture(78800-002) , pack(78800-002) , label(78800-002)

Revised: 9/2020
Document Id: af5c0244-fd2b-30ad-e053-2995a90ae8e3
Set id: a798a17f-8b04-250e-e053-2995a90a023d
Version: 3
Effective Time: 20200915
 
Octapod, S.A de C.V.