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NDC 70518-3262-00 Sore Throat Logenzes 15; 3.6 mg/1; mg/1 Details

Sore Throat Logenzes 15; 3.6 mg/1; mg/1

Sore Throat Logenzes is a ORAL LOZENGE in the HUMAN OTC DRUG category. It is labeled and distributed by REMEDYREPACK INC.. The primary component is BENZOCAINE; MENTHOL.

Product Information

NDC	70518-3262
Product ID	70518-3262_e39e2f2f-a9a4-ee66-e053-2995a90a52c6
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Sore Throat Logenzes
Proprietary Name Suffix	Sore Throat
Non-Proprietary Name	Benzocaine and Menthol
Product Type	HUMAN OTC DRUG
Dosage Form	LOZENGE
Route	ORAL
Active Ingredient Strength	15; 3.6
Active Ingredient Units	mg/1; mg/1
Substance Name	BENZOCAINE; MENTHOL
Labeler Name	REMEDYREPACK INC.
Pharmaceutical Class	Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part356
Listing Certified Through	2023-12-31

Package

Package Images

NDC 70518-3262-00 (70518326200)

Pricing Information	N/A
NDC Package Code	70518-3262-0
Billing NDC	70518326200
Package	18 BLISTER PACK in 1 CARTON (70518-3262-0) / 18 LOZENGE in 1 BLISTER PACK
Marketing Start Date	2021-11-02
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 5115bd75-96ca-4888-b06d-94bcd885a90e Details

SPL UNCLASSIFIED SECTION

Drug Facts

SPL UNCLASSIFIED SECTION

Active ingredients (in each lozenge)	Purpose
Benzocaine 15 mg	Oral pain reliever
Menthol 3.6 mg	Oral pain reliever

Uses

temporary relief of occasional

sore throat
sore mouth
minor mouth irritation
pain associated with canker sores

Warnings

Allergy alert

Do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine or any other 'caine' anesthetics.

Sore throat warning

If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea or vomiting consult a doctor promptly.

Do not use in a child under 5 years of age.

Stop use and ask a doctor or dentist if

sore mouth symptoms do not improve in 7 days
irritation, pain or redness persists or worsens
swelling, rash or fever develops

If pregnant or breast-feeding, ask a health professional before use.

Keep this and all drugs out of the reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Do not exceed recommended dosage.

Directions

adults and children 5 years or older: allow lozenge to dissolve slowly in the mouth; may be repeated every 2 hours as needed or as directed by a doctor or dentist.
children under 5 years of age: ask a doctor

Other information

tamper evident packaging: Do not use if outer box or blister is open or damaged.
store at room temperature
protect contents from moisture

Inactive ingredients

Glucose syrup, N&A flavoring, propylene glycol, red #40, sucrose, and water. Soybean oil used as processing aid.

Questions?

Call 1-800-616-2471

SPL UNCLASSIFIED SECTION

Repackaged and Distributed By:

Remedy Repack, Inc.

625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

PRINCIPAL DISPLAY PANEL

DRUG: Sore Throat LogenzesSore Throat Sore Throat

GENERIC: Benzocaine and Menthol

DOSAGE: LOZENGE

ADMINSTRATION: ORAL

NDC: 70518-3262-0

COLOR: red

FLAVOR: CHERRY

SHAPE: ROUND

SCORE: No score

SIZE: 18 mm

PACKAGING: 18 in 1 BLISTER PACK

OUTER PACKAGING: 18 in 1 CARTON

ACTIVE INGREDIENT(S):

MENTHOL 3.6mg in 1
BENZOCAINE 15mg in 1

INACTIVE INGREDIENT(S):

FD&C RED NO. 40
PROPYLENE GLYCOL
WATER
CORN SYRUP
ALLYL SUCROSE
HYDROGENATED SOYBEAN OIL

INGREDIENTS AND APPEARANCE

SORE THROAT LOGENZES SORE THROAT

benzocaine and menthol lozenge

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:70518-3262(NDC:0904-6255)
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5)	BENZOCAINE	15 mg
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	3.6 mg

Ingredient Name	Strength
Inactive Ingredients
FD&C RED NO. 40 (UNII: WZB9127XOA)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
CORN SYRUP (UNII: 9G5L16BK6N)
ALLYL SUCROSE (UNII: VI3D59RW0U)
HYDROGENATED SOYBEAN OIL (UNII: A2M91M918C)

Product Characteristics
Color	red	Score	no score
Shape	ROUND	Size	18mm
Flavor	CHERRY	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:70518-3262-0	18 in 1 CARTON	11/02/2021
1		18 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part356	11/02/2021

Labeler - REMEDYREPACK INC. (829572556)

Revised: 7/2022

Document Id: e39e2f2f-a9a4-ee66-e053-2995a90a52c6

Set id: 5115bd75-96ca-4888-b06d-94bcd885a90e

Version: 4

Effective Time: 20220712

Search by Drug Name or NDC

NDC 70518-3262-00 Sore Throat Logenzes 15; 3.6 mg/1; mg/1 Details

Sore Throat Logenzes 15; 3.6 mg/1; mg/1

Product Information

Package

Package Images

NDC 70518-3262-00 (70518326200)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL 5115bd75-96ca-4888-b06d-94bcd885a90e Details

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

Uses

Warnings

Allergy alert

Sore throat warning

Directions

Other information

Inactive ingredients

Questions?

SPL UNCLASSIFIED SECTION

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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