GIANT EAGLE SPRING FRESH ANTISEPTIC- eucalyptol, menthol, methyl salicylate, thymol mouthwash

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

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Active ingredient:
Eucalyptol 0.092%, Menthol 0.042%, Methyl Salicylate 0.060%, Thymol 0.064%, Antiplaque/Antigingivitis
Available from:
Apollo Health and Beauty Care Inc.
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
helps reduce plaque that leads to  - gingivitis - bleeding gums
Authorization status:
OTC monograph not final
Authorization number:
63148-020-33

GIANT EAGLE SPRING FRESH ANTISEPTIC- eucalyptol, menthol, methyl salicylate,

thymol mouthwash

Apollo Health and Beauty Care Inc.

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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Drug Facts

Active ingredients

Eucalyptol 0.092%

Menthol 0.042%

Methyl Salicylate 0.060%

Thymol 0.064%

Purps e

Antiplaque/Antigingivitis

Us es

helps reduce plaque that leads to

gingivitis

bleeding gums

Warnings

Stop use and ask a dentist if

gingivitis, bleeding, or redness persists for more than 2 weeks.

you have painful or swollen gums, pus from the gum line, loose teeth, or increasing spacing

between the teeth. These may be signs or symptoms fo periodontitis, a serious form of gum disease.

Keep out of reach of children under 6 years of age.

If more than used for rinsing is accidentallly swallowed, get medical help or contact a Poison Control

Center immediately.

Directions

Adults and children 12 years of age and older: vigorously swish 20 milliliters of rinse between

your teeth twice a day for 30 seconds and then spit out. Do not swallow the rinse.

Children 6 years to under 12 years of age: supervise use.

Children under 6 years of age: do not use.

Other information

This rinse is not intended to replace brushing or flossing

Store at room temperature. Cold weather may cloud this product. Its antiseptic properties are not

affected.

Inactive ingredients

Water (Aqua), Alcohol (21.6%), Sorbitol, Poloxamer 407, Flavor (Aroma), Benzoic Acid, Sodium

Benzoate, Sodium Saccharin, Green 3 (CI 42053), Yellow 10 (CI 47005).

Label copy

GIANT EAGLE SPRING FRESH ANTISEPTIC

eucalyptol, menthol, methyl salicylate, thymol mouthwash

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:6 3148 -0 20

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

EUCALYPTO L (UNII: RV6 J6 6 0 4TK) (EUCALYPTOL - UNII:RV6 J6 6 0 4TK)

EUCALYPTOL

0 .9 2 mg in 1 mL

MENTHO L (UNII: L7T10 EIP3A) (MENTHOL - UNII:L7T10 EIP3A)

MENTHOL

0 .42 mg in 1 mL

METHYL SALICYLATE (UNII: LAV5U50 22Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)

METHYL SALICYLATE

0 .6 0 mg in 1 mL

THYMO L (UNII: 3J50 XA376 E) (THYMOL - UNII:3J50 XA376 E)

THYMOL

0 .6 4 mg in 1 mL

Inactive Ingredients

Ingredient Name

Stre ng th

WATER (UNII: 0 59 QF0 KO0 R)

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

SO RBITO L (UNII: 50 6 T6 0 A25R)

PO LO XAMER 4 0 7 (UNII: TUF2IVW3M2)

BENZO IC ACID (UNII: 8 SKN0 B0 MIM)

SO DIUM BENZO ATE (UNII: OJ245FE5EU)

Apollo Health and Beauty Care Inc.

SACCHARIN SO DIUM (UNII: SB8 ZUX40 TY)

FD&C GREEN NO . 3 (UNII: 3P3ONR6 O1S)

D&C YELLO W NO . 10 (UNII: 35SW5USQ3G)

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End

Date

1

NDC:6 3148 -0 20 -

10 0 0 mL in 1 BOTTLE, PLASTIC; Type 0 : No t a Co mbinatio n

Pro duc t

0 9 /11/20 19

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

0 9 /11/20 19

Labeler -

Apollo Health and Beauty Care Inc. (201901209)

Registrant -

Apollo Health and Beauty Care Inc. (201901209)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Apo llo Health and Beauty Care Inc.

20 19 0 120 9

ma nufa c ture (6 3148 -0 20 )

Revised: 9/2019

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