DUKAL STING RELIEF PAD- benzocaine swab

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5), ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302)

Available from:

Dukal LLC

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

Topical Anesthetic Antiseptic

Authorization status:

OTC monograph not final

Summary of Product characteristics

DUKAL STING RELIEF PAD- BENZOCAINE SWAB
DUKAL LLC
----------
_DRUG FACTS_
ACTIVE INGREDIENTS
Benzocaine, 6% w/v
Isopropyl Alcohol 60% w/v
PURPOSE
Topical Anesthetic
Antiseptic
DIRECTIONS
Apply to affected area 3-4 times daily. For adults and children 2
years of age and older.
Children under 2 years; consult physician.
DO NOT USE
In the eyes. If contact occurs, rinse thoroughly with water
STOP USE
If irritation, redness or other symptoms develop. Consult a doctor if
the condition
persists or gets worse.
_CAUTION_ Flammable
KEEP OUT OF REACH OF CHILDREN.
If swallowed, get medical help or contact a Poison Control Center
right away.
INACTIVE INGREDIENT
Purified Water
D07110607 Rev5
PRINCIPAL DISPLAY PANEL - 0.4 ML POUCH LABEL
DUKAL™
CORPORATION
REF
856
NDC 65517-0005-1
STING RELIEF PAD
FOR TEMPORARY RELIEF OF PAIN AND ITCHING ASSOCIATED WITH MINOR BURNS,
SCRAPES
AND INSECT BITES.
For External Use Only
1 POUCH
DUKAL CORPORATION • [phone]
Ronkonkoma, New York • www.dukal.com
Made in China, Hecho en China, Fabriqué en Chine
DUKAL STING RELIEF PAD
benzocaine swab
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN OTC DRUG
ITEM CODE (SOURCE)
NDC:65517-0005
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF
STRENGTH
STRENGTH
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5)
BENZ OCAINE
60 mg
in 1 mL
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL -
UNII:ND2M416302)
ISOPROPYL
ALCOHOL
0.6 mL
in 1 mL
INACTIVE INGREDIENTS
INGREDIENT NAME
STRENGTH
WATER (UNII: 059QF0KO0R)
PACKAGING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START
DATE
MARKETING END
DATE
1
NDC:65517-
0005-1
0.4 mL in 1 POUCH; Type 0: Not a Combination
Product
06/01/2010
MARKETING INFORMATION
MARKETING
CATEGORY
APPLICATION NUMBER OR MONOGRAPH
CITATION
MARKETING START
DATE
MARKETING END
DATE
OTC Monograph Drug
M003
06/01/2010
Dukal LLC
LABELER -
Dukal LLC (791014871)
Revised: 10/2023