GIANT EAGLE COOL BURST ANTISEPTIC- eucalyptol, menthol, methyl salicylate, thymol mouthwash

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

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Preparatomtale Preparatomtale (SPC)
12-09-2019

Aktiv ingrediens:

Eucalyptol 0.092%, Menthol 0.042%, Methyl Salicylate 0.060%, Thymol 0.064%, Antiplaque/Antigingivitis

Tilgjengelig fra:

Apollo Health and Beauty Care Inc.

Administreringsrute:

ORAL

Resept typen:

OTC DRUG

Indikasjoner:

helps reduce plaque that leads to - gingivitis - bleeding gums

Autorisasjon status:

OTC monograph not final

Preparatomtale

                                GIANT EAGLE COOL BURST 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%
PURPOS 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 fore 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 of 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 accidentally 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).
LABE COPY
GIANT EAGLE COOL BURST ANTISEPTIC
eucalyptol, menthol, methyl salicylate, thymol mouthwash
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:6 3148 -0 19
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
                                
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