Petra Hand Sanitizer 75% Alcohol

Petra Hand Sanitizer 75 Alcohol by

Drug Labeling and Warnings

Petra Hand Sanitizer 75 Alcohol by is a Otc medication manufactured, distributed, or labeled by Petra Hygienic Systems Int Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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.

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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
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 (248228199)

Revised: 1/2023

Document Id: f19bb3ee-7ab1-e3a0-e053-2a95a90ad9d6

34390-5

Set id: b48fcbd3-c6bf-44ec-8043-1e7ac56422c1

Version: 6

Effective Time: 20230106