ALCOHOL- isopropyl alcohol swab

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302)

Available from:

Dalian Rongbang Medical Healthy Devices Co., Ltd.

INN (International Name):

ISOPROPYL ALCOHOL

Composition:

ISOPROPYL ALCOHOL 7 mL in 10 mL

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

To clean injection and other catheter sites. Apply swabstick to skin.

Authorization status:

OTC monograph final

Summary of Product characteristics

ALCOHOL- ISOPROPYL ALCOHOL SWAB
DALIAN RONGBANG MEDICAL HEALTHY DEVICES 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 SWABSTICKS
Two swabsticks saturated with 70% isopropyl alcohol.
Apply swabstick to skin.
water
To clean injection and other catheter sites.
Apply swabstick to skin.

For external use only
Discard after single use

isopropyl alcohol 70 %

ALCOHOL
isopropyl alcohol swab
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:49 9 53-28 0 1
Dalian Rongbang Medical Healthy Devices Co., Ltd.
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRE NG TH
ISO PRO PYL ALCO HO L (UNII: ND2M416 30 2) (ISOPROPYL ALCOHOL -
UNII:ND2M416 30 2)
ISOPROPYL ALCOHOL 7 mL in 10 mL
INACTIVE INGREDIENTS
INGREDIENT NAME
STRE NG TH
WATER (UNII: 0 59 QF0 KO0 R)
PACKAG ING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START DATE
MARKETING END DATE
1
NDC:49 9 53-28 0 1-2
1 mL in 1 POUCH; Type 0 : No t a Co mbinatio n Pro duct
0 7/0 2/20 10
2
NDC:49 9 53-28 0 1-3
3 mL in 1 POUCH; Type 0 : No t a Co mbinatio n Pro duct
0 7/0 2/20 10
MARKETING INFORMATION
MARKE TING CATE GORY
APPLICATION NUMBE R OR MONOGRAPH CITATION
MARKE TING START DATE
MARKE TING END DATE
OTC mo no graph final
pa rt344
0 7/0 2/20 10
LABELER -
Dalian Rongbang Medical Healthy Devices Co., Ltd. (529882730)
REGISTRANT -
Dalian Rongbang Medical Healthy Devices Co., Ltd. (529882730)
ESTABLISHMENT
NAME
AD D RE S S
ID/FEI
BUSINE SS OPE RATIONS
Dalian Ro ngbang Medical Healthy Devices Co ., Ltd.
529 8 8 2730
ma nufa c ture (49 9 53-28 0 1)
Revised: 11/2016