PUROX HAND SANITIZER- alcohol gel
Purox

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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Active Ingredient

Alcohol 85% v/v

Purpose

Antimicrobial

Use

Hand Sanitizer to help reduce bacteria on the skin.

Warnings

Flammable. Keep away from heat or flame

For external use only

When using this product

do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.

Stop use and ask a doctor if

irritation or rash appears and lasts.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Do not use

in children less than 2 months of age
on open skin wounds

Directions

Place enough product in your palm to thoroughly spread on both hands and rub into th skin until dry.
Children under 6 years old should be supervised when using this product.

Other information:

store between 106F (41C)
may discolor certain fabrics or surfaces

Inactive ingredients:

Deionized Water, Aloe, Triethanolamine, Carbomer

image description

PUROX HAND SANITIZER
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:78186-001
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	85 L in 100 L

Ingredient Name	Strength
Inactive Ingredients
ALOE (UNII: V5VD430YW9)	0.05 L in 100 L
TROLAMINE (UNII: 9O3K93S3TK)	0.03 L in 100 L
POLYACRYLIC ACID (250000 MW) (UNII: 9G2MAD7J6W)	1.45 L in 100 L
WATER (UNII: 059QF0KO0R)	13.47 L in 100 L

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:78186-001-04	3.785 L in 1 BOTTLE; Type 0: Not a Combination Product	07/08/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	07/08/2020

Labeler - Purox (121224718)

Name	Address	ID/FEI	Business Operations
Establishment
Purox		121224718	manufacture(78186-001)