ALCOHOL WET WIPES- wet wipes swab DISINFECTING WIPES- wet wipes swab ANTIBACTERIAL WET WIPES- wet wipes swab ALCOHOL WET TISS

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M), BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)

Available from:

SHANDONG PROVINCE RUNHE SANITARY MATERIALS CO.,LTD.

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Authorization status:

OTC monograph not final

Summary of Product characteristics

ALCOHOL WET WIPES- WET WIPES SWAB
DISINFECTING WIPES- WET WIPES SWAB
ANTIBACTERIAL WET WIPES- WET WIPES SWAB
ALCOHOL WET TISSUE- WET TISSUE SWAB
SHANDONG PROVINCE RUNHE SANITARY MATERIALS 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._
----------
ALCOHOL WET WIPES
wet wipes swab
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN OTC DRUG
ITEM CODE (SOURCE)
NDC:74439-002
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRENGTH
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)
ALCOHOL
30 g in 100 g
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM -
UNII:7N6JUD5X6Y)
BENZ ALKONIUM
CHLORIDE
0.624 g
in 100 g
INACTIVE INGREDIENTS
INGREDIENT NAME
STRENGTH
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
DIDECYLDIMONIUM CHLORIDE (UNII: JXN40O9Y9B)
WATER (UNII: 059QF0KO0R)
EDETATE DISODIUM (UNII: 7FLD91C86K)
DECYL GLUCOSIDE (UNII: Z17H97EA6Y)
PRODUCT CHARACTERISTICS
COLOR
white
SCORE
SHAPE
SIZE
FLAVOR
IMPRINT CODE
CONTAINS
PACKAGING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START
DATE
MARKETING END
DATE
1
NDC:74439-002-
01
50 g in 1 PACKET; Type 0: Not a Combination
Product
04/13/2020
MARKETING INFORMATION
MARKETING
CATEGORY
APPLICATION NUMBER OR MONOGRAPH
CITATION
MARKETING START
DATE
MARKETING END
DATE
OTC monograph not
final
part333A
04/13/2020
DISINFECTING WIPES
wet wipes swab
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN OTC DRUG
ITEM CODE (SOURCE)
NDC:74439-004
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRENGTH
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL -
UNII:ND2M416302)
ISOPROPYL ALCOHOL
75 g in 100 g
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM -
UNII:7N6JUD5X6Y)
BENZ ALKONIUM
CHLORIDE
0.1 g
in 100 g
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P) (CETYLPYRIDINIUM -
UNII:CUB7JI0JV3)
CETYLPYRIDINIUM
CHLORIDE