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:

Jianerkang Medical Co., Ltd

INN (International Name):

Isopropyl Alcohol

Composition:

Isopropyl Alcohol 70 mL in 100 mL

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

Antiseptic USE For skin cleansing prior to injection. - with electrocautery procedures - In the eyes. If contact occurs,flush eyes with water

Authorization status:

OTC monograph not final

Summary of Product characteristics

ALCOHOL- ISOPROPYL ALCOHOL SWAB
JIANERKANG MEDICAL CO., LTD
----------
ALCOHOL SWABSTICK
ACTIVE INGREDIENT
Isopropyl Alcohol 70%
PURPOSE
Antiseptic
USES
USE For skin cleansing prior to injection.
WARNINGS
For external use only.
Flammable. Keep away from fire or flame.
DO NOT USE
with electrocautery procedures
In the eyes. If contact occurs,flush eyes with water
KEEP OUT OF REACH OF CHILDREN
condition persists or gets worse or lasts for more than 72 hours
DIRECTIONS
Apply in a circular motion from injection site outward.Discard after
singly use.
STORAGE
Store at room temperature 15°-30℃ 59°-86°F)
INACTIVE INGREDIENTS
Purified Water
PACKAGE LABEL - PRINCIPAL DISPLAY PANEL
ALCOHOL
isopropyl alcohol swab
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN OTC DRUG
ITEM CODE (SOURCE)
NDC:34645-1042
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF
STRENGTH
STRENGTH
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL -
UNII:ND2M416302)
ISOPROPYL
ALCOHOL
70 mL
in 100 mL
INACTIVE INGREDIENTS
INGREDIENT NAME
STRENGTH
WATER (UNII: 059QF0KO0R)
Jianerkang Medical Co., Ltd
PACKAGING
# ITEM CODE
PACKAGE DESCRIPTION
MARKETING START
DATE
MARKETING END
DATE
1
NDC:34645-
1042-1
1 in 1 POUCH
06/11/2015
1
21 mL in 1 APPLICATOR; Type 0: Not a
Combination Product
MARKETING INFORMATION
MARKETING
CATEGORY
APPLICATION NUMBER OR MONOGRAPH
CITATION
MARKETING START
DATE
MARKETING END
DATE
OTC Monograph Drug
M003
06/11/2015
LABELER -
Jianerkang Medical Co., Ltd (530968767)
ESTABLISHMENT
NAME
ADDRESS
ID/FEI
BUSINESS OPERATIONS
Jianerkang Medical Co., Ltd
530968767
manufacture(34645-1042)
Revised: 10/2023