ORAL PAIN RELIEF- benzocaine and benzalkonium chloride gel

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

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Active ingredient:
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5), BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)
Available from:
Anicare Pharmaceuticals Pvt. Ltd
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
Oral pain reliever Antiseptic ■ for the temporary relief of pain due to toothaches ■ to help protect against infection in minor oral irritation ■ more than directed ■ for more than 7 days unless directed by a physician or healthcare provider ■ swelling, rash or fever develops ■ irritation, pain or redness persists or worsens ■ symptoms do not improve in 7 days
Authorization status:
OTC monograph not final
Authorization number:
47046-156-01, 47046-156-02

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ORAL PAIN RELIEF- benzocaine and benzalkonium chloride gel

Anicare Pharmaceuticals Pvt. 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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Oral Pain Relief Gel

Active Ingredients

Benzocaine 20%

Benzalkonium Chloride 0.1%

Purpose

Oral pain reliever

Antiseptic

Use

■ for the temporary relief of pain due to toothaches

■ to help protect against infection in minor oral irritation

Warnings

Methemoglobinemia warning: Use of this product may cause methemoglobinemia, a serious condition

that must be treated promptly because it reduce the amount of oxygen carried in blood. This can occur

even if you have used this product before. Stop use and seek immediate medical attention if you or a

child in your care develops: pale, gray, or blue colored skin (cyanosis)

headache

rapid heart rate

shortness of breath

dizziness or lightheadness

fatigue or lack of energy

Allergy alert:do not use this product if you have a history of allergy to local anesthetics such as

procaine, butacaine or other "caine" anesthetics

Do not use

■ more than directed

■ for more than 7 days unless directed by a physician or healthcare provider

Stop use and ask a physician if

■ swelling, rash or fever develops

■ irritation, pain or redness persists or worsens

■ symptoms do not improve in 7 days

Keep out of reach of children

In case of overdose or allergic reaction get medical help or contact a Poison Control Center right

away.

Directions

■ adults and children 2 years of age and over: apply a small amount of the product to the cavity and

around the gum surrounding the teeth Use up to 4 times daily or as directed by a physician or healthcare

provider

■ children under 12 years of age: should be supervised in the use of this product

■ children under 2 years of age: Do not use

Other information

■ this preparation is intended for use in cases ot toothache, only as a temporary expedient until a

physican can be consulted

■ do not use continuously

■ avoid using toothpaste or drinking soft drinks or fruit juices for at least one hour after applying

■ do not use if tube seal under cap is broken, missing or if the tube tip is cut prior to opening

Inactive ingredients

ammonium glycyrrhizate, flavor, polyethylene glycol, sodium saccharin, sorbic acid, purified water,

FD&C Yellow#5, FD&C Red#40

Package Label

Oral Pain Relief Gel

NET WT. 0.5 oz (14 g)

ORAL PAIN RELIEF

benzocaine and benzalkonium chloride gel

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:470 46 -156

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

0 .2 g in 1 g

BENZALKO NIUM CHLO RIDE (UNII: F5UM2KM3W7) (BENZALKONIUM -

UNII:7N6 JUD5X6 Y)

BENZALKONIUM

CHLORIDE

0 .0 1 g

in 1 g

Inactive Ingredients

Ingredient Name

Stre ng th

AMMO NIUM GLYCYRRHIZATE (UNII: 3VRD35U26 C)

PO LYETHYLENE GLYCO L, UNSPECIFIED (UNII: 3WJQ0 SDW1A)

SACCHARIN SO DIUM (UNII: SB8 ZUX40 TY)

SO RBIC ACID (UNII: X0 45WJ9 8 9 B)

WATER (UNII: 0 59 QF0 KO0 R)

FD&C YELLO W NO . 5 (UNII: I753WB2F1M)

Anicare Pharmaceuticals Pvt. Ltd

FD&C RED NO . 4 0 (UNII: WZB9 127XOA)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:470 46 -156 -0 2

1 in 1 CARTON

12/0 9 /20 20

1

NDC:470 46 -156 -0 1

14 g in 1 TUBE; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph no t final

pa rt356

12/0 9 /20 20

Labeler -

Anicare Pharmaceuticals Pvt. Ltd (916837425)

Registrant -

Anicare Pharmaceuticals Pvt. Ltd (916837425)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Anicare Pharmaceuticals Pvt. Ltd

9 16 8 37425

ma nufa c ture (470 46 -156 )

Revised: 12/2020

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