BGECARE ALCOHOL PREP PAD ISOPROPYL ALCOHOL SWAB- 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:

BOSTON BGECARE INC

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

Antiseptic For preparation of skin prior to injection Do not use: - with electrocautery procesures - in the eyes - on mucus membranes - on irritated skin 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

BGECARE ALCOHOL PREP PAD ISOPROPYL ALCOHOL SWAB- ISOPROPYL
ALCOHOL SOLUTION
BOSTON BGECARE INC
_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._
----------
81316-001 ALCOHOL PREP PAD
ACTIVE INGREDIENT(S)
Isopropyl Alcohol 70%
PURPOSE
Antiseptic
USE
For preparation of skin prior to injection
WARNINGS
For external use only.
Flammable. Keep away from fire or flame
DO NOT USE:
with electrocautery procesures
in the eyes
on mucus membranes
on irritated skin
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 FOR USE
Wipe injection site vigorously and discard
OTHER INFORMATION
Protect from freezing and avoid excessive heat
INACTIVE INGREDIENTS
Purified Water
BGECARE ALCOHOL PREP PAD ISOPROPYL ALCOHOL SWAB
isopropyl alcohol solution
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN OTC DRUG
ITEM CODE (SOURCE)
NDC:81316-001
ROUTE OF ADMINISTRATION
TOPICAL
BOSTON BGECARE INC
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:81316-
001-01
100 in 1 BOX
12/29/2020
1
1 in 1 POUCH
1
0.3 mL in 1 APPLICATOR; Type 0: Not a
Combination Product
2
NDC:81316-
001-02
200 in 1 BOX
12/29/2020
2
1 in 1 POUCH
2
0.3 mL in 1 APPLICATOR; Type 0: Not a
Combination Product
3
NDC:81316-
001-03
100 in 1 BOX
12/29/2020
3
1 in 1 POUCH
3
1 mL in 1 APPLICATOR; Type 0: Not a Combination
Product
4
NDC:81316-
001-04
200 in 1 BOX
12/29/2020
4
1 in 1 POUCH
4
1 mL in 1 APPLICATOR; Type 0: Not a Combination
Product
MARKETING INFORMATION
MARKETING
CATEGORY