MAGIC XTREME XTRA HAND SANITIZER- ethyl alcohol gel 
ENSOBRETADOS Y DERIVADOS 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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MAGIC XTREME XTRA HAND SANITIZER 2 mL

DRUG FACTS

ACTIVE INGREDIENT

Ethyl Alcohol 72%

PURPOSE

Antibacterial

USES

Hand sanitizer to decrease bacteria on the skin.

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

■ Wet hands thoroughly. Allow to dry without wiping.

■ 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

MAGIC XTREME XTRA HAND SANITIZER 2 mL (NDC 78885-002-00)

Magic Xtreme Hand Sanitizer 2 mL

MAGIC XTREME XTRA HAND SANITIZER 
ethyl alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78885-002
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
GLYCERIN (UNII: PDC6A3C0OX)  
WATER (UNII: 059QF0KO0R)  
CARBOMER 934 (UNII: Z135WT9208)  
TRIETHANOLAMINE SULFATE (UNII: MV1V89M17O)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:78885-002-002 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/15/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A01/15/2021
Labeler - ENSOBRETADOS Y DERIVADOS S.A. DE C.V. (813382660)
Registrant - ENSOBRETADOS Y DERIVADOS S.A. DE C.V. (813382660)
Establishment
NameAddressID/FEIBusiness Operations
ENSOBRETADOS Y DERIVADOS S.A. DE C.V.813382660manufacture(78885-002)

Revised: 1/2021
Document Id: b96395f9-b25a-7e56-e053-2a95a90a8c80
Set id: b96395f9-b259-7e56-e053-2a95a90a8c80
Version: 1
Effective Time: 20210115
 
ENSOBRETADOS Y DERIVADOS S.A. DE C.V.