R-ZERO ETHYL ALCOHOL ANTISEPTIC HAND SANITIZING FRAGRANCE FREE- ethyl alcohol gel

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

R-Zero Systems, Inc.

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

Antiseptic • 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

R-ZERO ETHYL ALCOHOL ANTISEPTIC HAND SANITIZING FRAGRANCE FREE-
ETHYL ALCOHOL GEL
R-ZERO SYSTEMS, INC.
_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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RZERO ETHYL ALCOHOL ANTISEPTIC HAND SANITIZING GEL _FRAGRANCE FREE_
_DRUG FACTS_
_ACTIVE INGREDIENT_
Ethyl alcohol 70% 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
• rub hands lightly until dry
• do not rinse
• supervise children under 6 years of age when using this product to
avoid swallowing
_OTHER INFORMATION_
store below 105˚F (40˚C)
_INACTIVE INGREDIENTS_
acrylates/vinyl isodecanoate crosspolymer, aloe vera (_Aloe
barbadensis_) leaf juice, alpha
tocopherol acetate, glycerin, isopropyl myristate, panthenol, peg-6,
water (aqua)
_QUESTIONS? _+1-801-823-0314
YOU MAY ALSO REPORT SERIOUS SIDE EFFECTS TO THIS PHONE NUMBER. Mon-Fri
8am -
5pm pst
MANUFACTURED FOR : R-Zero Systems, Inc.
345 Bearcat Drive, Suite 100, South Salt Lake, UT 84115
MADE IN USA OF U.S. AND IMPORTED COMPONENTS
PACKAGING
R-Zero Systems, Inc.
R-ZERO ETHYL ALCOHOL ANTISEPTIC HAND SANITIZING
FRAGRANCE FREE
ethyl alcohol gel
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN OTC DRUG
ITEM CODE (SOURCE)
NDC:81835-111
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE M