Hand Sanitizer by ECOTOMORROW LLC / AZS INDUSTRIA E COMERCIO EIRELI

Hand Sanitizer by

Drug Labeling and Warnings

Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by ECOTOMORROW LLC, AZS INDUSTRIA E COMERCIO EIRELI. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

HAND SANITIZER- alcohol spray 
ECOTOMORROW LLC

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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This is a hand sanitizer manufactured according to the OTC Monograph not final part 333E.

The hand sanitizer is manufactured using the following ingredients:

  1. Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (70%, volume/volume (v/v)).
  2. Glycerol (1.60% v/v).
  3. Cymbopogon Flexuosos Leaf Oil.
  4. Menthol.
  5. Methna Arvensis Leaf Oil.
  6. Aqua (purified water)

The firm does not add other active or inactive ingredients. Different or additional ingredients may impact the quality and potency of the product.

Active Ingredient(s)

Alcohol 70% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Use

  • For washing hands to decrease bacteria on skin.
  • Recommended for repeated use.

Warnings

For external use only.

Flammable, keep away from heat or flame

Do not use

For external use only.

When using this product

  • avoid contact with eyes.
  • if contact occurs, flush thoroughly with water.
  • avoid contact with broken skin

Stop use and ask a doctor if redness or irritation appears and lasts

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

Directions

  • Wet hands thoroughly with product and allow to dry without wiping.
  • Supervise children in the use of this product.
  • Use only as directed.

Other information

  • Store at room temperature 68-77F
  • May discolor certain fabrics or surfaces.

Inactive ingredients

aqua (purified water), glycerin, cymbopogon flexuosus leaf oil, menthol, mentha arvencis leaf oil

Package Label - Principal Display Panel

Package Label complete

Package Label PDP on spray bottle

120mL NDC: 77770-002-01

HAND SANITIZER 
alcohol spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 77770-002
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
GLYCERIN (UNII: PDC6A3C0OX) 1.6 mL  in 100 mL
MENTHOL (UNII: L7T10EIP3A)  
WATER (UNII: 059QF0KO0R)  
CYMBOPOGON FLEXUOSUS LEAF (UNII: 7LJ4Y1UJG7)  
MENTHA ARVENSIS LEAF OIL (UNII: 1AEY1M553N)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 77770-002-01120 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product08/01/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E08/01/202007/31/2023
Labeler - ECOTOMORROW LLC (117522249)
Establishment
NameAddressID/FEIBusiness Operations
AZS INDUSTRIA E COMERCIO EIRELI944838856manufacture(77770-002)

Revised: 5/2022
 

Trademark Results [Hand Sanitizer]

Mark Image

Registration | Serial
Company
Trademark
Application Date
HAND SANITIZER
HAND SANITIZER
88958909 not registered Live/Pending
MAISON BLANCHE, LLC
2020-06-10

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