SPECTRUM- ethyl alcohol gel

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Medline Industries, LP

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

Antiseptic - to decrease bacteria on the skin that could cause disease - recommended for repeat use

Authorization status:

OTC monograph not final

Summary of Product characteristics

SPECTRUM- ETHYL ALCOHOL GEL
MEDLINE INDUSTRIES, LP
_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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009 SPECTRUM ADVANCED 70% PACKET
_ACTIVE INGREDIENT_
Ethyl alcohol 70% v/v
_PURPOSE_
Antiseptic
_USES_
to decrease bacteria on the skin that could cause disease
recommended for repeat use
_WARNINGS_
FOR EXTERNAL USE ONLY.
FLAMMABLE: KEEP AWAY FROM HEAT AND FLAME.
WHEN USING THIS PRODUCT
keep out of eyes. In case of contact with eyes, flush thoroughly with
water.
avoid contact with broken skin
do not inhale or ingest
STOP USE AND ASK A DOCTOR IF
irritation or redness develops
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
for children under 6, use only under adult supervision
not recommended for infants
_OTHER INFORMATION_
_OTHER INFORMATION_
do not store above 105ºF
may discolor some fabrics
harmful to wood finishes and plastics
_INACTIVE INGREDIENTS_
Acrylates/C10-30 alkyl acrylate crosspolymer, aloe barbadensis leaf
juice,
diisopropylamine, glycerin, isopropyl myristate, tocopheryl acetate,
water
MANUFACTURING INFORMATION
Manufactored for Medline industries, LP
Three Lakes Drive, Northfield, IL 60093 USA
Made in USA with US and Foreign components
www.medline.com
1-800-MEDLINE
REF: HH70GPACKET
V1 RA22VJO
PACKAGE LABEL
SPECTRUM
ethyl alcohol gel
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN OTC DRUG
ITEM CODE (SOURCE)
NDC:53329-009
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
Medline Industries, LP
INGREDIENT NAME
BASIS OF STRENGTH
STRENGTH
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)
ALCOHOL
70 g in 100 mL
INACTIVE INGREDIENTS
INGREDIENT NAME
STRENGTH
DIISOPROPYLAMINE (UNII: BR9JLI40NO)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
GLYCERIN (UNI