ACTIVEX ANTIBACTERIAL HAND SANITIZER ACTIVE- alcohol gel

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Evyap Sabun Yag Gliserin Sanayi Ve Ticaret Anonim Sirketi

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

For hand washing to decrease bacteria on the skin

Authorization status:

OTC monograph not final

Summary of Product characteristics

ACTIVEX ANTIBACTERIAL HAND SANITIZER ACTIVE- ALCOHOL GEL
EVYAP SABUN YAG GLISERIN SANAYI VE TICARET ANONIM SIRKETI
_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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ACTIVEX ANTIBACTERIAL HAND SANITIZER ACTIVE
_DRUG FACTS_
_ACTIVE INGREDIENT_
Ethyl alcohol 75%
_PURPOSE_
Antiseptic
_USE_
For hand washing to decrease bacteria on the skin
_WARNINGS_
- For external use only.
- Flammable, keep away from fire or flame.
DO NOT USE
in the eyes
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.
_OTHER INFORMATION_
- Store in original packaging in a cool and dry place, out of direct
sunlight.
- May discolor certain fabrics or surfaces.
_INACTIVE INGREDIENTS_
Water, glycerin, acrylates/C 10-300 alkyl acrylate crosspolymer,
fragrance, triethanolamine, isopropyl
myristate.
_QUESTIONS OR COMMENTS_
1 (224) - 408-0663
PACKAGE LABELING:
ACTIVEX ANTIBACTERIAL HAND SANITIZER ACTIVE
alcohol gel
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:6 430 9 -0 0 1
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 .75 mL in 1 mL
INACTIVE INGREDIENTS
INGREDIENT NAME
STRE NG TH
WATER (UNII: 0 59 QF0 KO0 R)
GLYCERIN (UNII: PDC6 A3C0 OX)
TRO LAMINE (UNII: 9 O3K9 3S3TK)
ISO PRO PYL MYRISTATE (UNII: 0 RE8 K4LNJS)
PACKAG ING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START DATE
MARKETING END DATE
1
NDC:6 430 9 -0 0 1-0 1 10 0 mL in 1 BOTTLE; Type 0 : No t a Co
mbinatio n Pro duct
0 9 /0 1/20 20
MARKETING INFORMATION
MARKE TING CATE GORY
APPLICATION NUMBE R OR MONOGRAPH CITATION
MARKE TI