PROTECT CARE HAND SANITIZER - USA- ethyl alcohol gel 
Antisépticos de México, 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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Protect Care 70% USA Made

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(aqua), Glycerin, Carbomer, Triethanolamine

Package Label - Principal Display Panel 250 mL

250 ml NDC: 76554-003-01

ProtectCare 250

Package Label - Principal display panel 500mL

Protetcare USA 500ml500 mL NDC: 76554-030-02

PACKAGE LABEL- Principal Display Panel 1000mL

Protetcare USA 1000ml1000 mL NDC: 76554-030-03

PROTECT CARE HAND SANITIZER - USA 
ethyl alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76554-030
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
TROLAMINE (UNII: 9O3K93S3TK) 1 mL  in 100 mL
GLYCERIN (UNII: PDC6A3C0OX) 1 mL  in 100 mL
CARBOMER 940 (UNII: 4Q93RCW27E) 1 mL  in 100 mL
WATER (UNII: 059QF0KO0R) 27 mL  in 100 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76554-030-02500 mL in 1 BOTTLE; Type 0: Not a Combination Product06/05/2020
2NDC:76554-030-01250 mL in 1 BOTTLE; Type 0: Not a Combination Product06/05/2020
3NDC:76554-030-031000 mL in 1 BOTTLE; Type 0: Not a Combination Product06/05/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A06/05/2020
Labeler - Antisépticos de México, S.A. de C.V. (951576637)
Registrant - Antisépticos de México, S.A. de C.V. (951576637)
Establishment
NameAddressID/FEIBusiness Operations
Antisépticos de México, S.A. de C.V.951576637manufacture(76554-030)

Revised: 11/2020
Document Id: b34fc24e-154c-f43d-e053-2995a90a1052
Set id: a75d25a7-1e25-717f-e053-2a95a90a6d93
Version: 4
Effective Time: 20201104
 
Antisépticos de México, S.A. de C.V.