HAND SPRITZER- ethyl alcohol gel

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Hand Spritzer Llc

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

Antiseptic Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Authorization status:

OTC monograph not final

Summary of Product characteristics

HAND SPRITZER- ETHYL ALCOHOL GEL
HAND SPRITZER 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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HAND SPRITZER
DRUG FACTS
ACTIVE INGREDIENT(S)
Ethyl alcohol 80% v/v
PURPOS E
Antiseptic
US E(S )
Hand Sanitizer to help reduce bacteria that potentially can cause
disease.
For use when soap and water are not available.
WARNINGS
FOR EXTERNAL USE ONLY. FLAMMABLE. KEEP AWAY FROM HEAT OR FLAME
DO NOT USE
• in children less than 2 months of age
• on open skin wounds
WHEN USING THIS PRODUCT keep out of eyes, ears, and mouth. In case of
contact with eyes,rinse eyes
thoroughly with water.
STOP USE AND ASK A DOCTOR IF irritation or rash occurs. These may be
signs of a serious condition.
KEEP OUT OF REACH OF CHILDREN. If swallowed, get medical help or
contact a Poison Control Center right
away.
DIRECTIONS
• Place enough product on hands to cover all surfaces. Rub hands
together until dry.
• Supervise children under 6 years of age when using this product to
avoid swallowing.
OTHER INFORMATION
• Store between 15-30C (59-86F)
• Avoid freezing and excessive heat above 40C (104F)
INACTIVE INGREDIENTS RODI water, hydrogen peroxide, glycerin,
methocellulose, carbopol, aloe
ETHYL ALCOHOL ANTISEPTIC
80% TOPICAL SOLUTION
HAND SANITIZER
NON-STERILE SOLUTION
PACKAGING
HAND SPRITZER
ethyl alcohol gel
PRODUCT INFORMATION
Hand Spritzer Llc
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:77276 -428
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
8 0 mL in 10 0 mL
INACTIVE INGREDIENTS
INGREDIENT NAME
STRE NG TH
WATER (UNII: 0 59 QF0 KO0 R)
HYDRO GEN PERO XIDE (UNII: BBX0 6 0 AN9 V)
GLYCERIN (UNII: PDC6 A3C0 OX)
METHYLCELLULO SE, UNSPECIFIED (UNII: Z9 44H5SN0 H)
CARBO MER HO MO PO LYMER, UNSPECIFIED TYPE (UNII: 0 A5MM30 7FC)