INSECT STING RELIEF PAD- benzocaine, alcohol cloth

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5), ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)

Available from:

Hubei Changjian Medical Products Co., Ltd.

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

Topical Anesthetic Antiseptic For the temporary relief of pain and itching associated with minor burns, scrapes and insect bites.

Authorization status:

OTC monograph not final

Summary of Product characteristics

INSECT STING RELIEF PAD- BENZOCAINE, ALCOHOL CLOTH
HUBEI CHANGJIAN MEDICAL PRODUCTS CO., LTD.
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INSECT STING RELIEF PAD
DRUG FACTS-INSECT STING RELIEF PAD
ACTIVE INGREDIENTS:
Benzocaine,6% w/v
SD alcohol,60% w/v
PURPOSE:
Topical Anesthetic
Antiseptic
USE:
For the temporary relief of pain and itching associated with minor
burns, scrapes and
insect bites.
WARNINGS:
For external use only.
DO NOT USE:
In eyes, on broken skin, deep puncture wounds. If unusual redness,
swelling, irritation
or other symptoms occur, consult a physician immediately.
KEEP OUT OF REACH OF CHILDREN.
If swallowed, get medical help or contact a Poison Control Center
right away.
FLAMMABLE
- keep away from fire or flame. Avoid contact with eyes. If this
happens, rinse
thoroughly with water.
DIRECTIONS:
Adults and children 2 years of age and older; apply to affected area
not more than 3 to
4 times daily. Children under 2 years of age consult a doctor.
INACTIVE INGREDIENT:
Purified water.
PACKAGE LABELING: 82996-003-01
INSECT STING RELIEF PAD
benzocaine, alcohol cloth
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN OTC DRUG
ITEM CODE (SOURCE)
NDC:82996-003
Hubei Changjian Medical Products Co., Ltd.
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 g
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)
ALCOHOL
600 mg in 1 g
INACTIVE INGREDIENTS
INGREDIENT NAME
STRENGTH
WATER (UNII: 059QF0KO0R)
PACKAGING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START
DATE
MARKETING END
DATE
1
NDC:82996-003-
01
1 in 1 POUCH
11/01/2022
1
0.45 g in 1 POUCH; Type 0: Not a Combination
Product
MARKETING INFORMATION
MARKETING
CATEGORY
APPLICATION NUMBER OR MONOGRAPH
CITATION
MARKETING START
DATE
MARKETING END
DATE
OTC Monograph Drug
M017
11/01/2022
LABELER -
Hubei Changjian Medical Products Co., Ltd. (699440035)
Revised: 11/2023