SANITOL ANTISEPTIC LIQUID

SANITOL ANTISEPTIC by

Drug Labeling and Warnings

SANITOL ANTISEPTIC by is a Otc medication manufactured, distributed, or labeled by Spicy World Of Usa Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SANITOL ANTISEPTIC- benzalkonium chloride liquid 
Spicy World Of Usa Inc

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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SANITOL ANTISEPTIC LIQUID

Drug Facts

Active ingredient

Benzalkonium chloride 1.2% w/v

Purpose

First aid antiseptic

Uses

first aid to help prevent the risk of infection in minor cuts scrapes, burns

Warnings

For external use only

Do not use

in the eyes or apply over large areas of the body. In case of deep or puncture wounds, animal bites,

or serious burns, consult a doctor

not suitable for infants

When using this product do not get into eyes. In case of contact, rinse eyes thoroughly with water

do not mix with other chemicals

Stop use and ask a doctor if  the condition persists or gets worse. Do not use longer than 1 week unless directed by a doctor

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

Directions

always use diluted

clean the affected area. Dilute 2 tablespoon (2 cap full or 30 mL) in 10.1 fl oz fl.oz (300 mL) of water

apply a small amount of this product on the affected area 1 to 3 times daily

may be covered with a sterile bandage

if bandaged, let dry first

Other information

store between 15-30°C (59-86°F)

avoid freezing and excessive heat above 40°C (104°F)

Inactive ingredients

caramel, DMDM hydantoin, limonene, pine oil, water

Questions? +1-713-661-2972

You may also report serious side effects to this phone number.

Mon-Fri 9:00 AM - 5:00 PM

SAFE | GENTLE | EFFECTIVE

Sanitol liquid is a safe and gentle antiseptic making it perfect for family use.

Distributed by: Spicy World of USA, Inc

Houston, TX , USA, 77074

Made in the UK

Not tested on Animals

Packaging

SANITOL ANTISEPTIC 
benzalkonium chloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79722-101
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	1.2 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
CARAMEL (UNII: T9D99G2B1R)
DMDM HYDANTOIN (UNII: BYR0546TOW)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
WHITE PINE OIL (UNII: HA5CX6676U)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79722-101-17	500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/01/2020	09/30/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	08/01/2020	09/30/2023

Labeler - Spicy World Of Usa Inc (193002763)

Revised: 4/2021

Document Id: fa76cabd-56ad-4094-b074-8f5c140c5528

34390-5

Set id: 75cfd7ad-d863-40d0-83dd-20c19e9a3933

Version: 2

Effective Time: 20210409