ALCOHOL PREP- isopropyl alcohol swab

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Isopropyl alcohol 70% v/v

Available from:

PHOENIX HEALTHCARE SOLUTIONS, LLC

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

Antiseptic For preparation of the skin prior to injection; to decrease germs in minor cuts and scrapes.

Authorization status:

OTC monograph not final

Summary of Product characteristics

ALCOHOL PREP- ISOPROPYL ALCOHOL SWAB
PHOENIX HEALTHCARE SOLUTIONS, LLC
----------
SENECA LARGE ALCOHOL PREP PADS
ACTIVE INGREDIENTS
Isopropyl alcohol 70% v/v
PURPOSE
Antiseptic
USE:
For preparation of the skin prior to injection; to decrease germs in
minor cuts and
scrapes.
WARNINGS:
For external use only. Flammable; keep away from fire and flame.
KEEP OUT OF REACH OF CHILDREN.
If swallowed, get medical help or contact a Poison Control Center
immediately.
CAUTION:
Do not apply to irritated skin.
DO NOT USE
in the eyes, or on mucous membranes. In case of deep or puncture
wounds, consult a
doctor.
DIRECTIONS:
Wipe injection site vigorously.
OTHER INFORMATION:
Store at room temperature
INACTIVE INGREDIENTS:
Water
PRINCIPAL DISPLAY PANEL
Phoenix Healthcare Solutions,LLC
An Innovative Medical Manufacturer
NDC 60913-009-02
100 Individual Pads
Alcohol Prep Pads
Sterile - Large
For Individual, Professional and Hospital Use
Saturated with 70% v/v Isopropyl Alcohol for external use only
Latex Free
Sterile in unopened, undamaged package
PIN DOT WOVEN
ALCOHOL PREP
isopropyl alcohol swab
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN OTC DRUG
ITEM CODE (SOURCE)
NDC:60913-009
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)
PHOENIX HEALTHCARE SOLUTIONS, LLC
PACKAGING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START
DATE
MARKETING END
DATE
1
NDC:60913-009-
02
100 in 1 CARTON
02/19/2015
1
1 mL in 1 PACKET; 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
02/19/2015
LABELER -
PHOENIX HEALTHCARE SOLUTIONS, LLC (079146847)
ESTABLISHMENT
NAME
ADDRESS
ID/FEI
BUSINESS OPERATIONS
Phoenix Innovative Healthcare Manufacturers Private Limited
650743854
manufacture(60913-009)
Revised: 11