FRESHWORKS ANTISEPTIC HAND SANITIZER LEMON ZEST FRAGRANCE- alcohol gel

United States - English - NLM (National Library of Medicine)

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Active ingredient:
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)
Available from:
Envelope Group, LLC
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
- hand sanitizer to decrease bacteria on the skin - recommended for repeated use - for use when soap and water are not available
Authorization status:
OTC monograph not final
Authorization number:
80890-001-01, 80890-001-02, 80890-001-03

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FRESHWORKS ANTISEPTIC HAND SANITIZER LEMON ZEST 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 Lemon Zest Fragrance

Drug Facts

Active ingredient

Ethyl alcohol 65% v/v

Purpose

Antiseptic

Uses

hand sanitizer to decrease bacteria on the skin

recommended for repeated use

for use when soap and water are not available

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

wet hands thoroughly with product and allow to dry without wiping

supervise children under 6 years of age when using this product to avoid swallowing

Other information

store between 15-30°C (59-86°F)

avoid freezing and excessive heat above 40°C (104°F)

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

Package Labeling:100ml

Package Labeling:250ml

FRESHWORKS ANTISEPTIC HAND SANITIZER LEMON ZEST FRAGRANCE

alcohol gel

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:8 0 8 9 0 -0 0 1

Route of Administration

TOPICAL

Envelope Group, LLC

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

ALCO HO L (UNII: 3K9 9 58 V9 0 M) (ALCOHOL - UNII:3K9 9 58 V9 0 M)

ALCOHOL

0 .6 5 mL in 1 mL

Inactive Ingredients

Ingredient Name

Stre ng th

CARBO MER HO MO PO LYMER TYPE C ( ALLYL PENTAERYTHRITO L CRO SSLINKED) (UNII: 4Q9 3RCW27E)

ALO E VERA LEAF (UNII: ZY8 1Z8 3H0 X)

GLYCERIN (UNII: PDC6 A3C0 OX)

.ALPHA.-TO CO PHERO L (UNII: H4N8 55PNZ1)

TEA LEAF (UNII: GH42T47V24)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:8 0 8 9 0 -0 0 1-0 1 50 mL in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

12/0 4/20 20

2

NDC:8 0 8 9 0 -0 0 1-0 2 10 0 mL in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

12/0 4/20 20

3

NDC:8 0 8 9 0 -0 0 1-0 3 250 mL in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

12/0 4/20 20

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph no t final

pa rt333E

12/0 4/20 20

Labeler -

Envelope Group, LLC (833284370)

Revised: 12/2020

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