PURENIQUE HYGIENE SOLUTIONS ANTISEPTIC WIPES- benzalkonium chloride swab

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

benzalkonium chloride (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)

Available from:

JIANGMEN SHUIZIRUN SANITARY ARTICLES CO., LTD.

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

Antiseptic Clean and refreshes hands without soap and water.

Authorization status:

OTC monograph not final

Summary of Product characteristics

PURENIQUE HYGIENE SOLUTIONS ANTISEPTIC WIPES- BENZALKONIUM CHLORIDE
SWAB
JIANGMEN SHUIZIRUN SANITARY ARTICLES CO., 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._
----------
DRUG FACTS
ACTIVE INGREDIENT
Benzalkonium Chloride .......... 0.13 %
PURPOS E
Antiseptic
US ES :
Clean and refreshes hands without soap and water.
WARNINGS
For external use only. Stop use and consult doctor if skin irritation
develops.
KEEP OUT OF REACH OF CHILDREN.
if swallowed get medical help or contact a Poison Control Center right
away.
DIRECTIONS
Self-dries in seconds. Leave skin soft and smooth.
_OTHER INFORMATION: _
Storage and handling: Store in cool place.
INACTIVE INGREDIENTS:
Glycerol, 1,2-propanediol, 2-phenoxyetanol, Didecyl dimethyl ammonium
chloride, 2-propandiol,
Antibacterial synerists, Stabilizer, Water
PURENIQUE HYGIENE SOLUTIONS ANTISEPTIC WIPES
benzalkonium chloride swab
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:71734-331
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRE NG TH
BENZA LKO NIUM CHLO RIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6
JUD5X6 Y)
benzalko nium chlo ride
0 .13 g in 10 0 g
INACTIVE INGREDIENTS
INGREDIENT NAME
STRE NG TH
WA TER (UNII: 0 59 QF0 KO0 R)
GLYCERIN (UNII: PDC6 A3C0 OX)
PRO PYLENE GLYCO L (UNII: 6 DC9 Q16 7V3)
PACKAG ING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START DATE
MARKETING END DATE
1
NDC:71734-331-0 1
2.0 g in 1 POUCH; Type 0 : No t a Co mbinatio n Pro duct
10 /30 /20 20
MARKETING INFORMATION
MARKE TING CATE GORY
APPLICATION NUMBE R OR MONOGRAPH CITATION
MARKE TING START DATE
MARKE TING END DATE
OTC mo no graph no t final
pa rt333A
10 /30 /20 20
JIANGMEN SHUIZIRUN SANITARY ARTICLES CO., LTD.
LABELER -
JIANGMEN SHUIZIRUN SANIT ARY ART ICLES CO., LT D. (544530534)
ESTABLISHMENT
NAME
AD D RE S S
ID/FEI
BUSINE SS OPE RATIONS
JIANGMEN SHUI