INSECT STING RELIEF- benzocaine, alcohol swab

United States - English - NLM (National Library of Medicine)

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Active ingredient:
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5), ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)
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
Authorization number:
50814-041-01, 50814-041-02, 50814-041-03

INSECT STING RELIEF- benzocaine, alcohol swab

GFA Production (Xiamen) Co., Ltd.

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.

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INSECT STING RELIEF PAD

DRUG FACTS - Insect Sting Relief Pad

Active Ingredient:

Benzocaine, 6% w/v

SD alcohol, 60% w/v

Purpos e:

Topical Anesthetic

Anesthetic

Us e:

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 T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:50 8 14-0 41

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

BENZO CAINE (UNII: U3RSY48 JW5) (BENZOCAINE - UNII:U3RSY48 JW5)

BENZOCAINE

6 0 mg in 1 mL

ALCO HO L (UNII: 3K9 9 58 V9 0 M) (ALCOHOL - UNII:3K9 9 58 V9 0 M)

ALCOHOL

6 0 0 mg in 1 mL

Inactive Ingredients

Ingredient Name

Stre ng th

WATER (UNII: 0 59 QF0 KO0 R)

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End

Date

1

NDC:50 8 14-

0 41-0 1

0 .18 mL in 1 POUCH; Type 2: Prefilled Drug Delivery Device/System

(syringe, patch, etc.)

0 6 /29 /20 18

2

NDC:50 8 14-

0 41-0 2

0 .53 mL in 1 POUCH; Type 0 : No t a Co mbinatio n Pro duct

0 6 /29 /20 18

3

NDC:50 8 14-

0 41-0 3

0 .225 mL in 1 POUCH; Type 2: Prefilled Drug Delivery Device/System

(syringe, patch, etc.)

0 1/0 1/20 19

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

GFA Production (Xiamen) Co., Ltd.

OTC mo no graph no t final

pa rt348

0 6 /29 /20 18

Labeler -

GFA Production (Xiamen) Co., Ltd. (421256261)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

GFA Pro ductio n (Xiamen) Co ., Ltd.

421256 26 1

ma nufa c ture (50 8 14-0 41)

Revised: 10/2019

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