INSECT STING RELIEF- benzocaine, alcohol swab

Ország: Egyesült Államok

Nyelv: angol

Forrás: NLM (National Library of Medicine)

Aktív összetevők:

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

Beszerezhető a:

GFA Production (Xiamen) Co., Ltd.

Az alkalmazás módja:

TOPICAL

Recept típusa:

OTC DRUG

Terápiás javallatok:

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

Engedélyezési státusz:

OTC monograph not final

Termékjellemzők

INSECT STING RELIEF- BENZOCAINE, ALCOHOL SWAB
GFA PRODUCTION (XIAMEN) CO., LTD.
----------
INSECT STING RELIEF PAD
DRUG FACTS - INSECT STING RELIEF PAD
ACTIVE INGREDIENT:
Benzocaine, 6% w/v
SD alcohol, 60% w/v
PURPOSE:
Topical Anesthetic
Anesthetic
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 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 Contrl Center right
away.
Flammable - keep away from fire or flame. Avoid contact with eyes. If
this happens, rinse
thoroughly with water
INACTIVE INGREDIENTS:
Purified water.
PACKAGE LABELING:
INSECT STING RELIEF
benzocaine, alcohol swab
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN OTC DRUG
ITEM CODE (SOURCE)
NDC:50814-041
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 DATE
MARKETING
END DATE
1
NDC:50814-
041-01
0.18 mL in 1 POUCH; Type 2: Prefilled Drug Delivery
Device/System (syringe, patch, etc.)
06/29/2018
2
NDC:50814-
041-02
0.53 mL in 1 POUCH; Type 0: Not a Combination Product
06/29/2018
3
NDC:50814-
041-03
0.225 mL in 1 POUCH; Type 2: Prefilled Drug Delivery
Device/System (syringe, patch, etc.)
01/01/2019
GFA Production (Xiamen) Co., Ltd.
MARKETING INFORMATION
MARKETING
CATEGORY
APPLICATION NUMBER OR MONOGRAPH
CITATION
MARKETING START
DATE
MARKETING END
DATE
OTC Monograph Drug
M017
06/29/2018
LABELER -
GFA Production (Xiamen) Co., Ltd. (421256261)
ESTABLISHMENT
NAME
ADDRESS
ID/FEI
BUSINESS OPERATIONS
GFA Production (Xiamen) Co., Ltd.
421256261
manu