INSECT STING RELIEF- benzocaine, alcohol cloth

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Topical Anesthetic, Antiseptic

Available from:

GFA Production (Xiamen) Co., Ltd.

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

- 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- BENZOCAINE, ALCOHOL CLOTH
GFA PRODUCTION (XIAMEN) CO., LTD.
----------
INSECT STING RELIEF PAD
DRUG FACTS
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.
Flammable, keep away from fire or flame.
DO NOT USE
On broken skin, deep puncture wounds. Avoid contact with eyes. If
happens, rinse
thoroughly with water.
STOP USE
If unsual 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.
DIRECTIONS
Apply to affected area nor more than 3 to 4 times daily.
Children under 2 years: consult physician.
OTHER INFORMATION
Store at room temperature 15°C-30°C (59°F-86°F)
INACTIVE INGREDIENTS
Purified water.
PACKAGE LABELING:
INSECT STING RELIEF
benzocaine, alcohol cloth
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN OTC DRUG
ITEM CODE (SOURCE)
NDC:50814-040
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
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)
ALCOHOL
600 mg in 1 mL
INACTIVE INGREDIENTS
INGREDIENT NAME
STRENGTH
WATER (UNII: 059QF0KO0R)
PACKAGING
# ITEM CODE
PACKAGE DESCRIPTION
MARKETING START
MARKETING END
GFA Production (Xiamen) Co., Ltd.
# ITEM CODE
PACKAGE DESCRIPTION
MARKETING START
DATE
MARKETING END
DATE
1
NDC:50814-
040-01
100 in 1 BOX
11/11/2018
1
1 in 1 PACKAGE
1
0.15 mL in 1 PACKAGE; 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
11/11/2018
LABELER -
GFA Production (Xiamen) Co., Ltd. (421256261)
ESTABLISHMENT
NAME
ADDRESS
ID/FEI
BUSINESS OPERATIONS
GFA Production (Xiamen) Co., Ltd.
421256261
manu