FRESHWORKS ANTISEPTIC HAND SANITIZER LAVENDER FIELDS FRAGRANCE- alcohol gel 
Envelope Group, 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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Freshworks Antiseptic Hand Sanitizer Lavender Fields Fragrance

Drug Facts

Active ingredient

Ethyl alcohol 65% v/v

Purpose

Antiseptic

Uses

Warnings

Flammable, keep away from fire/flame For external use only

Do not use

  • in children less than 2 months of age
  • on open skin wounds

When using this product

do not get into eyes. In case of contact, rinse eyes thoroughly with water

Stop use and ask a doctor if

  • irritation and redness develop
  • condition persists for more than 72 hours

Keep out of reach of children.

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

Directions

Other information

Inactive ingredients

0,30% Carbomer 940 0.50% Aloe Vera Juice 0,50% Glycerine 0,20% Fragrance 0,03% Vitamin E 0,3 % TEA

Questions?

+1-833-451-1635 You may also report serious side effects to this phone number. Mon-Fri 9:00 AM - 5:00 PM

Package Labeling:50ml

bottle7

Package Labeling:100ml

BOttle8

Package Labeling:250ml

Bottle9

FRESHWORKS ANTISEPTIC HAND SANITIZER LAVENDER FIELDS FRAGRANCE 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80890-002
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.65 mL  in 1 mL
Inactive Ingredients
Ingredient NameStrength
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
GLYCERIN (UNII: PDC6A3C0OX)  
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
TEA LEAF (UNII: GH42T47V24)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:80890-002-0150 mL in 1 BOTTLE; Type 0: Not a Combination Product12/04/2020
2NDC:80890-002-02100 mL in 1 BOTTLE; Type 0: Not a Combination Product12/04/2020
3NDC:80890-002-03250 mL in 1 BOTTLE; Type 0: Not a Combination Product12/04/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E12/04/2020
Labeler - Envelope Group, LLC (833284370)

Revised: 12/2020
Document Id: b5fb65d2-5055-19d2-e053-2a95a90a481b
Set id: b5fb65d2-5054-19d2-e053-2a95a90a481b
Version: 1
Effective Time: 20201208
 
Envelope Group, LLC