HAND SANITIZER- alcohol gel 
GREEN ELV NUTRITION, 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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Hand Sanitizer

Drug Facts

Active ingredients

Ethyl Alcohol 70% v/v

Purposes

Antimicrobial

Uses

Warnings

Flammable. Keep away from fire or flame.

For External Use Only.

When using this product,

do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.

Stop use & ask a doctor if

if irritation or redness develops and persists.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center immediately.

Directions

Other information

Inactive ingredients

Carbopol, Glycerin, Licorice Extract, Neem Extract, Propylene glicol, Triethanolamine, Water.

Question or comments?

+1(956) 612-8408

Package Labeling :250ml (Bag)

Bottle250ml

Package Labeling :250ml(Bottle)

Bottle 250ml

Package Labeling :1L

Bottle 1L

Package Labeling :30ml

Bottle 30ml

Package Labeling :500ml

Bottle500ml

Package Labeling :60ml

Bottle60ml

HAND SANITIZER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78659-000
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
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
GLYCERIN (UNII: PDC6A3C0OX)  
LICORICE (UNII: 61ZBX54883)  
AZADIRACHTA INDICA FLOWER (UNII: 3TE8A92UPM)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
TROLAMINE (UNII: 9O3K93S3TK)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:78659-000-01250 mL in 1 BAG; Type 0: Not a Combination Product05/04/2020
2NDC:78659-000-02250 mL in 1 BOTTLE; Type 0: Not a Combination Product05/04/2020
3NDC:78659-000-031000 mL in 1 BAG; Type 0: Not a Combination Product05/04/2020
4NDC:78659-000-0430 mL in 1 BOTTLE; Type 0: Not a Combination Product05/04/2020
5NDC:78659-000-05500 mL in 1 BAG; Type 0: Not a Combination Product05/04/2020
6NDC:78659-000-0660 mL in 1 BOTTLE; Type 0: Not a Combination Product05/04/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E05/04/2020
Labeler - GREEN ELV NUTRITION, S.A. DE C.V. (951578109)
Establishment
NameAddressID/FEIBusiness Operations
GREEN ELV NUTRITION, S.A. DE C.V.951578109manufacture(78659-000)

Revised: 6/2020
Document Id: a759a736-2134-2772-e053-2a95a90a99fc
Set id: a759a736-2133-2772-e053-2a95a90a99fc
Version: 1
Effective Time: 20200605
 
GREEN ELV NUTRITION, S.A. DE C.V.