FRESHWORKS ANTISEPTIC HAND SANITIZER LEMON ZEST FRAGRANCE- alcohol gel

Country: United States

Language: English

Source: NLM (National Library of Medicine)

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

Summary of Product characteristics

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?_
[phone] 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 M