DERMO REAL- ethyl alcohol gel 
Saflosa Industria Real, 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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Dermo Real® SKIN CARE Moisturising Hand Sanitizer 

Drug Facts

Active ingredient

Ethyl Alcohol 70% v/v

Purpose

Antiseptic

Uses

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.

Directions

Other information

Inactive ingredients

Carbomer, fragrance, glycerin, triethanolamine, water.

Kills 99.9% of Most Illness Causing Germs

with Glycerin

@Real Skin Care Mx

Manufactured by:

SAFLOSA INDUSTRIA REAL, S.A. DE C.V.
Calle Poza Rica No. 9 Col. Arbol Grande C.P. 33739
Cd. Camargo, Chihuahua, México.

Tels.: (648) 462-1417
www.saflosa.com         

www.realskincare.com.mx

Packaging

untitled

DERMO REAL 
ethyl alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78009-110
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 HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
GLYCERIN (UNII: PDC6A3C0OX)  
TROLAMINE (UNII: 9O3K93S3TK)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:78009-110-0630 mL in 1 BOTTLE; Type 0: Not a Combination Product05/24/2020
2NDC:78009-110-02960 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product05/24/2020
3NDC:78009-110-03960 mL in 1 BOTTLE; Type 0: Not a Combination Product05/24/2020
4NDC:78009-110-013785 mL in 1 BOTTLE; Type 0: Not a Combination Product05/24/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A05/24/2020
Labeler - Saflosa Industria Real, S.A. de C.V. (821354313)
Establishment
NameAddressID/FEIBusiness Operations
Saflosa Industria Real, S.A. de C.V.821354313manufacture(78009-110)

Revised: 5/2020
Document Id: e465a1ce-44d8-4e92-a36c-7688cc3ffc7d
Set id: dc09c55b-3c64-45c3-9e51-34b0b76e8563
Version: 1
Effective Time: 20200520
 
Saflosa Industria Real, S.A. de C.V.