PEARLS ANTISEPTIC WET WIPES ROSE- benzalkonium chloride patch

pearls Antiseptic Wet Wipes Rose by

Drug Labeling and Warnings

pearls Antiseptic Wet Wipes Rose by is a Otc medication manufactured, distributed, or labeled by Premier Brands Usa Llc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient

Benzalkonium chloride 0.38%

Purpose

Antiseptic

Uses

• wet wipes to decrease bacteria on the skin
•  recommended for repeated use
•  for use when soap and water are not available

Warnings

Flammable, keep away from fire/flame

For external use only

Do not use

• in children less than 2 months of age
• on open skin wounds
•  if you are allergic to any of the ingredients

When using this product  do not get into eyes. In case of contact, rinse eyes thoroughly with water for 15-20 minutes. Remove contact lenses, if present.

Stop use and ask a doctor if

• irritation and redness developlop
• condition 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 product and allow to dry without wiping
• discard wipe in trash receptacle after use
• supervise children under 6 years of age when using this product to avoid swallowing

Other information

• store between 15-30°C (59-86°F)
• avoid freezing and excessive heat above 40°C (104°F)
• may discolour certain fabric or surfaces

Inactive ingredients

water, peg 7glyceryl cocoate, polysorbate 20, cocamidopropyl betaine, phenoxyethanol, dehydroaceer, peg 7glyceryl cocoate,
polysorbate 20, cocamidopropyl betaine, phenoxyethanol, dehydroacetic acid, benzoic acid, fragrance, edetate sodium, citric acid

Questions?

+1-954-993-9149
You may also report serious side effects to this phone number.
Mon-Fri 9:00 AM - 5:00 PM

SPL UNCLASSIFIED SECTION

PURE FRESH, PERFUMIC, ULTRA SOFT, TRUSTED

ANTIBACTERIAL PROTECTION

ALCOHOL FREE

NEUTRAL pH 5,5

Clean your Hand 

KEEP YOUR FAMILY HYGIENICALLY CLEAN

Fresh Pearls Wipes are the quick and easy way. Keep your family hygienically clean and protected at home away. They are ideal for instant clean ups of hands or face. Keep hands clean whether you are at home or in travelling.
Convenient for us in healthcare, nursing stations, patient bedside, long-term nursing care, the home, offices, car, restaurants, health clubs, workshops ... whenever soap and water are not available

Distributed By:

PREMIER BRANDS USA LLC

Pompano Beach, FL 33060

MADE IN TURKEY

DRY PLACE AWAY FROM DIRECT SUNLIGHT

Packaging

INGREDIENTS AND APPEARANCE

PEARLS ANTISEPTIC WET WIPES ROSE 
benzalkonium chloride patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79361-104
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.38 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
PEG-7 GLYCERYL COCOATE (UNII: VNX7251543)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
DEHYDROACETIC ACID (UNII: 2KAG279R6R)
BENZOIC ACID (UNII: 8SKN0B0MIM)
EDETATE SODIUM (UNII: MP1J8420LU)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79361-104-08	80 in 1 PACKET	07/30/2020
1		4.59 g in 1 PATCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	07/30/2020

Labeler - Premier Brands Usa Llc (080225305)