EClean Rubbing Alcohol Denatured Ethyl Alcohol 70% Solution

EClean Rubbing Alcohol Denatured Ethyl Alcohol 70 Solution by

Drug Labeling and Warnings

EClean Rubbing Alcohol Denatured Ethyl Alcohol 70 Solution by is a Otc medication manufactured, distributed, or labeled by Eksa Mills, S.A. de C.V.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ECLEAN RUBBING ALCOHOL DENATURED ETHYL ALCOHOL 70 SOLUTION- alcohol gel 
Eksa Mills, 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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EClean Rubbing Alcohol Denatured Ethyl Alcohol 70% Solution

Drug Facts

Active Ingredient

Ethyl Alcohol 70% by volume

Purpose

First aid antiseptic

Use

First aid to help prevent the risk of infection in:

 minor cuts  scrapes  burns

Warnings

For external use only.

Flammable, keep way from spark, heat and flame.

Ask a doctor before use for

deep wounds, animal bites or serious burns   

When using this product

  • do not get into eyes
  • do not apply over large areas of the body
  • do not use longer than 1 week

Stop use and ask a doctor if

condition persists or gets worse

Keep out of reach of children.

In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

Directions

  • clean the affected area.
  • apply a small amount of this
  • product on the affected area 1 to 3 times daily
  • may be covered with sterile bandage
  • if bandaged, let it dry first.

Other Information

  • store at room temperature
  • will produce serious gastric disturbanes if taken internally.

Inactive Ingredient

Bitrex  Purified water.

Package Labeling:1000ml

Bottle

Package Labeling:500ml

Bottle2

ECLEAN RUBBING ALCOHOL DENATURED ETHYL ALCOHOL 70 SOLUTION 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 77538-006
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.7 mL  in 1 mL
Inactive Ingredients
Ingredient NameStrength
DENATONIUM BENZOATE (UNII: 4YK5Z54AT2)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 77538-006-021000 mL in 1 BOTTLE; Type 0: Not a Combination Product09/08/202001/04/2023
2NDC: 77538-006-01500 mL in 1 BOTTLE; Type 0: Not a Combination Product09/08/202001/04/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A09/08/202001/04/2023
Labeler - Eksa Mills, S.A. de C.V. (951573231)
Establishment
NameAddressID/FEIBusiness Operations
Eksa Mills, S.A. de C.V.951573231manufacture(77538-006)

Revised: 7/2022
Document Id: e2c1ac50-896b-865b-e053-2a95a90ac81c
Set id: aed32021-33af-7f6d-e053-2a95a90ac85a
Version: 3
Effective Time: 20220701