ONYX ADVANCED HAND SANITIZER- alcohol gel

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)

Available from:

ONYX PREMIERE LLC

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

Hand sanitizer to help reduce bacteria on the skin.

Authorization status:

OTC monograph not final

Summary of Product characteristics

ONYX ADVANCED HAND SANITIZER- ALCOHOL GEL
ONYX PREMIERE 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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ONYX ADVANCED HAND SANITIZER
DRUG FACTS
ACTIVE INGREDIENT
Ethyl alcohol 70% v/v
PURPOS E
Antimicrobial
US E:
Hand sanitizer to help reduce bacteria on the skin.
WARNINGS
FLAMMABLE. KEEP AWAY FROM FIRE OR FLAME. FOR EXTERNAL USE ONLY.
DO NOT
ingest, if swallowed seek medical help. Avoid contact with eyes.
KEEP OUT OF REACH OF CHILDREN.
Children under 6yrs old to use under adult supervision. In case of
irritation, discontinue use and consult
your doctor.
DIRECTIONS :
Apply the Gel on the hands and rub gently for 20 seconds until the
product evaporates.
OTHER INFORMATION:
Store below 106°F (41°C).
May discolor certain fabrics or surfaces.
INACTIVE INGREDIENTS:
demineralized water, glycerin, carbomer, triethanolamine, dmdm
hydantoin, aloe barbadensis extract,
iodopropynyl butylcarbamate, butylene glycol.
PACKAGE LABELING:
ONYX ADVANCED HAND SANITIZER
alcohol gel
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:7540 3-0 0 0
ONYX PREMIERE LLC
ROUTE OF ADMINISTRATION
TOPICAL
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 .7 mL in 1 mL
INACTIVE INGREDIENTS
INGREDIENT NAME
STRE NG TH
WATER (UNII: 0 59 QF0 KO0 R)
GLYCERIN (UNII: PDC6 A3C0 OX)
CARBO MER HO MO PO LYMER, UNSPECIFIED TYPE (UNII: 0 A5MM30 7FC)
TRO LAMINE (UNII: 9 O3K9 3S3TK)
DMDM HYDANTO IN (UNII: BYR0 546 TOW)
IO DO PRO PYNYL BUTYLCARBAMATE (UNII: 6 0 3P14DHEB)
BUTYLENE GLYCO L (UNII: 3XUS8 5K0 RA)
PACKAG ING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START DATE
MARKETING END DATE
1
NDC:7540 3-0 0 0 -0 1
250 mL in 1 POUCH; Type 0 : No t a Co mbinatio n Pro duct
0 4/0 1/20 20
MARKETING INFORMATION
MARKE TING CATE GORY
APPLICATION NUMBE R OR MONOGRAPH CITATI