SKIN CLEANSING WIPE- isopropyl alcohol solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

RFX+CARE Manufacturing Co., Ltd.

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

Antiseptic Cleanser For cleaning the skin and area around minor wounds and abrasions Do not use: - with electrocautery procesures - in the eyes. If contact occurs flush eyes with water Stop use: - if irritation and redness develop - if condition persists, consult your health care practitioner

Authorization status:

OTC monograph not final

Summary of Product characteristics

SKIN CLEANSING WIPE- ISOPROPYL ALCOHOL SOLUTION
RFX+CARE MANUFACTURING CO., LTD.
----------
82283-001
ACTIVE INGREDIENT(S)
Isopropyl Alcohol 70% v/v
PURPOSE
Antiseptic Cleanser
USE
For cleaning the skin and area around minor wounds and abrasions
WARNINGS
For external use only.
Flammable. Keep away from flame or fire
DO NOT USE:
with electrocautery procesures
in the eyes. If contact occurs flush eyes with water
STOP USE:
if irritation and redness develop
if condition persists, consult your health care practitioner
Keep out of reach of children. If swallowed, get medical help or
contact a Poison Control
Center right away
DIRECTIONS
Apply topically as needed to cleanse intended area
Discard affter single use
OTHER INFORMATION
Store at room temperature 15-30C (59-86F)
INACTIVE INGREDIENTS
Purified Water
SKIN CLEANSING WIPE
isopropyl alcohol solution
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN OTC DRUG
ITEM CODE (SOURCE)
NDC:82283-001
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)
PACKAGING
# ITEM CODE
PACKAGE DESCRIPTION
MARKETING START
DATE
MARKETING END
DATE
1
NDC:82283-
001-01
1 in 1 POUCH
10/01/2021
1
4 mL in 1 APPLICATOR; Type 0: Not a Combination
Product
2
NDC:82283-
001-02
10 in 1 POUCH
10/01/2021
2
10 mL in 1 APPLICATOR; Type 0: Not a
Combination Product
3
NDC:82283-
001-03
60 in 1 POUCH
10/01/2021
3
10 mL in 1 APPLICATOR; Type 0: Not a
RFX+CARE Manufacturing Co., Ltd.
3
Combination Product
MARKETING INFORMATION
MARKETING
CATEGORY
APPLICATION NUMBER OR MONOGRAPH
CITATION
MARKETING START
DATE
MARKETING END
DATE
OTC Monograph Drug
M005
09/30/2021
LABELER -
RFX+CARE Manufacturing Co., Ltd. (421146863)
ESTABLISHMENT
NAME
ADDRESS
ID/FEI
BUSINESS OPERATIONS
RFX+CARE Manufacturing Co., Ltd.
421146863
manufacture(82283-001)
Revised: 11/2023