BERNAL HAND SANITIZER- alcohol gel 
Inflatables LLC

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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Inflatables LLC-bernal-PLD 70% Hand Sanitizer

Drug Facts

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

Carbomer, Triethanolamine, Water

Package Label - Principal Display Panel

3785 mL / 1 Gallon Front Display NDC: 74541-270-37NDC: 74541-270-37

BERNAL HAND SANITIZER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74541-270
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
CARBOMER 940 (UNII: 4Q93RCW27E)  
TROLAMINE (UNII: 9O3K93S3TK)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:74541-270-0260 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product03/30/2020
2NDC:74541-270-04130 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product03/30/2020
3NDC:74541-270-06200 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product03/30/2020
4NDC:74541-270-08220 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product03/30/2020
5NDC:74541-270-17500 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product03/30/2020
6NDC:74541-270-341000 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product03/30/2020
7NDC:74541-270-0130 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product03/30/2020
8NDC:74541-270-373785 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 - Inflatables LLC (108619168)
Registrant - Quimica Magna de Mexico, S.A. de C.V. (951576195)
Establishment
NameAddressID/FEIBusiness Operations
Quimica Magna de Mexico, S.A. de C.V.951576195manufacture(74541-270)

Revised: 5/2020
Document Id: a605a085-27e2-6880-e053-2a95a90a7a54
Set id: a4e8bf1a-351e-8cde-e053-2a95a90af858
Version: 3
Effective Time: 20200519
 
Inflatables LLC