BIOTECH GEL 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:

BioTech Industries

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

Antiseptic For handwashing to decrease bacteria on the skin

Authorization status:

OTC monograph not final

Summary of Product characteristics

BIOTECH GEL HAND SANITIZER- ALCOHOL GEL
BIOTECH INDUSTRIES
_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._
----------
ACTIVE INGREDIENT
Ethyl Alcohol 80% v/v
PURPOS E
Antiseptic
US E
For handwashing to decrease bacteria on the skin
WARNINGS
FOR EXTERNAL USE ONLY.
FLAMMABLE. KEEP AWAY FROM HEAT OR FLAME
WHEN USING THIS PRODUCT do not use in or near the eyes. In case of
contact with eyes, rinse eyes
thoroughly with water. Avoid contact with broken skin. Do not inhale
or ingest.
STOP USE AND ASK A DOCTOR IF irritation and redness develop and
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 products and allow to dry without wiping.
For children under six years, use only under adult supervision.
Not recommended for infants.
INACTIVE INGREDIENTS
Glycerol, hydrogen peroxide, sterile distilled water or boiled cold
water, scent, rapid gel
PACKAGE LABEL - PRINCIPAL DISPLAY PANEL
BIOTECH GEL HAND SANITIZER
alcohol gel
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:7779 1-0 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
8 0 mL in 10 0 mL
INACTIVE INGREDIENTS
INGREDIENT NAME
STRE NG TH
GLYCERIN (UNII: PDC6 A3C0 OX)
HYDRO GEN PERO XIDE (UNII: BBX0 6 0 AN9 V)
WATER (UNII: 0 59 QF0 KO0 R)
PACKAG ING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START
DATE
MARKETING END
DATE
BioTech Industries
1
NDC:7779 1-0 0 1-
0 1
59 mL in 1 BOTTLE, PLASTIC; Type 0 : No t a Co mbinatio n
Pro duc t
0 5/0 3/20 20
2
NDC:7779 1-0 0 1-
0 2
118 mL in 1 BOTTLE, PLASTIC; Type 0 : No t a Co mbinatio n
Pro duc t
0 5/0 3/20 20
3
NDC:7779 1-0 0 1-
0 3
236 mL in 1 BOTTLE, PLASTIC; Type 0 : No t a Co mbinatio n