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NDC 69626-0048-06 NICE SORE THROAT Spearmint 1.4 g/177mL Details

NICE SORE THROAT Spearmint 1.4 g/177mL

NICE SORE THROAT Spearmint is a ORAL SPRAY in the HUMAN OTC DRUG category. It is labeled and distributed by Leosons Overseas Corp. The primary component is PHENOL.

Product Information

NDC	69626-0048
Product ID	69626-0048_b6fd9d0b-00f4-de3c-e053-2a95a90a1b0e
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	NICE SORE THROAT Spearmint
Proprietary Name Suffix	n/a
Non-Proprietary Name	Phenol
Product Type	HUMAN OTC DRUG
Dosage Form	SPRAY
Route	ORAL
Active Ingredient Strength	1.4
Active Ingredient Units	g/177mL
Substance Name	PHENOL
Labeler Name	Leosons Overseas Corp
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part356
Listing Certified Through	2023-12-31

Package

Package Images

NDC 69626-0048-06 (69626004806)

Pricing Information	N/A
NDC Package Code	69626-0048-6
Billing NDC	69626004806
Package	177 mL in 1 BOTTLE, SPRAY (69626-0048-6)
Marketing Start Date	2014-03-07
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 5fc68f04-ec15-11c0-e053-2a91aa0a1952 Details

Drug Facts

Active Ingredient & Purposes

Active Ingredients	Purposes
Phenol 1.4%	Oral Anesthetic/ Analgesic

Uses

For temporary relief of occasional minor irritation, pain, sore mouth, sore throat and pain associated with canker sores.

Warnings

Sore throat warning: Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea and vomiting may be serious. Consult doctor promptly. Do not use more than 2 days or administer to children under 3 years of age unless directed by doctor.

When using this product

do not use more than directed.

Stop use and ask a doctor if

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

If pregnant or breast feeding,

ask a health professional before use.

Keep this and all drugs out of reach of children.

In case of accidental overdose, seek professional assistance or contact a Poison Control Center right away.

Directions

apply to the affected area
allow to remain in place for at least 15 seconds, then spit out
use every 2 hours or as directed by a doctor or dentist

age	dose
adults and children 12 years of age and older	for each application, spray 5 times
children 3 to under 12 years	should be supervised in use of this product for each application, spray 3 times
children under 3 years of age	consult a doctor or dentist

Other Information

store at room temperature

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL IS TORN, BROKEN OR MISSING.

Inactive Ingredients

D&C green #5, D&C yellow #10, FD&C green #3, flavor, glycerin, propylene glycol, sodium saccharin, and water.

Questions?

1-855-452-9500 or email at [email protected]

Distributed by:

LEOSONS

Albany, New York 12205

Made in USA

Principal Display Panel

SUGAR FREE • ALCOHOL FREE • ASPIRIN FREE

N'ICE®

P H E N O L / O R A L A N E S T H E T I C

Sore Throat Spray

Fast acting, long lasting relief of minor sore throat and mouth pain

SPEARMINT FLAVOR

6 FL OZ (177 mL)

INGREDIENTS AND APPEARANCE

NICE SORE THROAT SPEARMINT

phenol spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:69626-0048
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
PHENOL (UNII: 339NCG44TV) (PHENOL - UNII:339NCG44TV)	PHENOL	1.4 g in 177 mL

Ingredient Name	Strength
Inactive Ingredients
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
GLYCERIN (UNII: PDC6A3C0OX)
D&C GREEN NO. 5 (UNII: 8J6RDU8L9X)
WATER (UNII: 059QF0KO0R)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)

Product Characteristics
Color	green	Score
Shape		Size
Flavor	SPEARMINT	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:69626-0048-6	177 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	03/07/2014

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part356	03/07/2014

Labeler - Leosons Overseas Corp (148605470)

Revised: 12/2020

Document Id: b6fd9d0b-00f4-de3c-e053-2a95a90a1b0e

Set id: 5fc68f04-ec15-11c0-e053-2a91aa0a1952

Version: 2

Effective Time: 20201221