E D HAND SANITIZER- ethyl alcohol gel 
ENSOBRETADOS Y DERIVADOS S.A. DE C.V. E&D

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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E&D HAND SANITIZER 1 mL

DRUG FACTS

ACTIVE INGREDIENT

Ethyl Alcohol 72%

PURPOSE

Antiseptic

USES

Hand sanitizer to help reduce bacteria that potentially can cause disease.

WARNINGS

For external use only. Flammable. Keep away from heat or flame

Do not use

■ in children less than 2 months of age

■ on open skin wounds

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.

Keep out of reach of children If swallowed get medical help or contact a Poison Control Center right away.

DIRECTIONS

■ Place enough product on hands to cover all surfaces. Rub hands together until dry.

■ Supervise children under 6 years of age when using this product to avoid swallowing.

OTHER INFORMATION

■ Store between 15-30C (59-86F)

■ Avoid freezing and excessive heat above 40C (104F)

INACTIVE INGREDIENTS

Carbopol, Glycerin, Triethanolamine, Water (Aqua).

QUESTIONS OR COMMENTS?

1-855-349-7735 or visit www.eydmx.com

E&D HAND SANITIZER 1 mL (NDC 78885-001-00)

E&D Hand Sanitizer 1 mL

E D HAND SANITIZER 
ethyl alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78885-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL72 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
TROLAMINE (UNII: 9O3K93S3TK)  
POLYACRYLIC ACID (8000 MW) (UNII: 73861X4K5F)  
GLYCERIN (UNII: PDC6A3C0OX)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:78885-001-001 mL in 1 PACKET; Type 0: Not a Combination Product06/15/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A06/15/2020
Labeler - ENSOBRETADOS Y DERIVADOS S.A. DE C.V. E&D (813382660)
Registrant - ENSOBRETADOS Y DERIVADOS S.A. DE C.V. E&D (813382660)
Establishment
NameAddressID/FEIBusiness Operations
ENSOBRETADOS Y DERIVADOS S.A. DE C.V. E&D813382660manufacture(78885-001)

Revised: 6/2020
Document Id: a83bda1f-f7ce-7f65-e053-2a95a90a1600
Set id: a83bda01-c234-173c-e053-2a95a90ab104
Version: 1
Effective Time: 20200615
 
ENSOBRETADOS Y DERIVADOS S.A. DE C.V. E&D