PETRA HAND SANITIZER 75 ALCOHOL- alcohol gel

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Petra Hygienic Systems Int Ltd

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

For hand sanitizing to decrease bacteria on the skin

Authorization status:

OTC monograph not final

Summary of Product characteristics

PETRA HAND SANITIZER 75 ALCOHOL- ALCOHOL GEL
PETRA HYGIENIC SYSTEMS INT LTD
_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._
----------
PETRA HAND SANITIZER 75% ALCOHOL
_DRUG FACTS_
_ACTIVE INGREDIENT_
Ethyl Alcohol 75% v/v
_PURPOSE_
Antiseptic
_USES_
For hand sanitizing to decrease bacteria on the skin
_WARNINGS_
- For External Use only. Flammable.
WHEN USING THIS PRODUCT
avoid contact with eyes and keep away from sources of heat. In case of
eye contact,
flush eyes with water.
STOP USE AND CONSULT A DOCTOR
if irritations occur.
_KEEP OUT OF REACH OF CHILDREN._
If swallowed get medical help or contact a Poison Control Center right
away.
_DIRECTIONS_
- Rub thoroughly into hands for at least 30 seconds. Allow to dry.
Supervise children
when they use this product. For occasional and personal domestic use
_NON MEDICINAL INGREDIENTS _
- Water and Carbomer Resin
PACKAGE LABELING:
PACKAGE LABELING:42326-207-02
PETRA HAND SANITIZER 75 ALCOHOL
alcohol gel
PRODUCT INFORMATION
Petra Hygienic Systems Int Ltd
PRODUCT TYPE
HUMAN OTC DRUG
ITEM CODE (SOURCE)
NDC:42326-207
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRENGTH
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)
ALCOHOL
0.75 mL in 1 mL
INACTIVE INGREDIENTS
INGREDIENT NAME
STRENGTH
WATER (UNII: 059QF0KO0R)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
PACKAGING
# ITEM CODE
PACKAGE DESCRIPTION
MARKETING START
DATE
MARKETING END
DATE
1
NDC:42326-
207-01
500 mL in 1 BOTTLE; Type 0: Not a Combination
Product
04/30/2020
08/01/2023
2
NDC:42326-
207-02
3780 mL in 1 BOTTLE; Type 0: Not a Combination
Product
06/25/2020
08/01/2023
MARKETING INFORMATION
MARKETING
CATEGORY
APPLICATION NUMBER OR MONOGRAPH
CITATION
MARKETING START
DATE
MARKETING END
DATE
OTC monograph not
final
part333E
04/30/2020
08/01/2023
LABELER -
Petra Hygienic Systems Int Ltd (24822