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NDC 00135-0590-04 AQUAFRESH 1.15 mg/g Details

AQUAFRESH 1.15 mg/g

AQUAFRESH is a DENTAL PASTE in the HUMAN OTC DRUG category. It is labeled and distributed by GlaxoSmithKline Consumer Healthcare Holdings (US) LLC. The primary component is SODIUM FLUORIDE.

MedlinePlus Drug Summary

Fluoride is used to prevent tooth decay. It is taken up by teeth and helps to strengthen teeth, resist acid, and block the cavity-forming action of bacteria. Fluoride usually is prescribed for children and adults whose homes have water that is not fluoridated (already has fluoride added). This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.

Related Packages: 00135-0590-04
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Fluoride

Product Information

NDC	00135-0590
Product ID	0135-0590_406bcedb-ab48-4b75-8e0a-0fa02064deda
Associated GPIs	97503000004400
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	AQUAFRESH
Proprietary Name Suffix	CAVITY PROTECTION
Non-Proprietary Name	sodium fluoride
Product Type	HUMAN OTC DRUG
Dosage Form	PASTE
Route	DENTAL
Active Ingredient Strength	1.15
Active Ingredient Units	mg/g
Substance Name	SODIUM FLUORIDE
Labeler Name	GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part355
Listing Certified Through	2024-12-31

Package

Package Images

NDC 00135-0590-04 (00135059004)

Pricing Information	N/A
NDC Package Code	0135-0590-04
Billing NDC	00135059004
Package	2 TUBE in 1 CARTON (0135-0590-04) / 158.8 g in 1 TUBE
Marketing Start Date	2016-11-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 5484999c-8e6f-430d-99a5-6893a2489467 Details

Active ingredient (Cavity Protection, Extra Fresh +Whitening, Multi Action Whitening)

Sodium fluoride 0.25% (0.15% w/v fluoride ion)

Active ingredient (ultimate white)

Sodium fluoride 0.24% (0.15% w/v fluoride ion)

Purpose

Anticavity

Use

aids in the prevention of dental cavities

Warnings

When using this product,

if irritation occurs discontinue use

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

If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Directions

•

adults and children 2 years and older:

•: apply toothpaste onto a toothbrush
•: brush teeth thoroughly, preferably after each meal, or at least twice a day, and not more than 3 times a day, or as directed by a dentist or doctor. Minimize swallowing. Spit out after brushing.
•: to minimize swallowing for children under 6 years of age, use a pea-sized amount and supervise brushing and rinsing until good habits are established.

•

children under 2 years of age: Consult a dentist or doctor

Other information

•: store below 30°C (86°F)

Inactive ingredients (Cavity Protection)

water, hydrated silica, sorbitol, glycerin, sodium lauryl sulfate, xanthan gum, flavor, titanium dioxide, PEG-8, sodium saccharin, carrageenan, red 30, blue 1

Inactive ingredients (Extra Fresh +Whitening)

water, hydrated silica, sorbitol, glycerin, sodium lauryl sulfate, flavor, xanthan gum, titanium dioxide, PEG-8, sodium saccharin, carrageenan, red 30, blue 1

Inactive ingredients (Multi Action Whitening)

water, hydrated silica, sorbitol, glycerin, PEG-8, sodium lauryl sulfate, xanthan gum, flavor, titanium dioxide, cocamidopropyl betaine, sodium citrate, sodium saccharin, zinc chloride, red 30, blue 1

Inactive ingredients (ultimate white)

water, hydrated silica, sorbitol, glycerin, pentasodium triphosphate, PEG-8, sodium lauryl sulfate, titanium dioxide, flavor, xanthan gum, sodium hydroxide, sodium saccharin, red 30, blue 1

Questions or comments?

Call toll-free 1-800-897-5623

Principal Display Panel

NDC 0135-0590-01

: Aquafresh®

fluoride toothpaste

triple protection®

•: healthy gums*
•: strong teeth
•: fresh breath

cavity protection

Sugar Acid Protection**

from Fluoride

cool mint

NET WT 5.6 OZ (158.8 g)

**With Sugar Acid Protection provided by fluoride, which strengthens enamel, creating a shield that protects the tooth surface against sugar acid attack.

*with twice daily brushing

ALWAYS FOLLOW THE LABEL

Trademarks are owned by or licensed to the GSK group of companies.

GSK Consumer Healthcare

Warren, NJ 07059

Made in Taiwan

1-800-897-5623

105263XA

Aquafresh Cavity Protection 5.6oz (158.8g) carton

Principal Display Panel

NDC 0135-0591-01

: Aquafresh®

fluoride toothpaste

triple protection®

•: healthy gums*
•: strong teeth
•: fresh breath

extra fresh +whitening

Sugar Acid Protection**

from Fluoride

fresh mint

NET WT 5.6 OZ (158.8 g)

**With Sugar Acid Protection provided by fluoride, which strengthens enamel, creating a shield that protects the tooth surface against sugar acid attack.

*with twice daily brushing

ALWAYS FOLLOW THE LABEL

Trademarks are owned by or licensed to the GSK group of companies.

GSK Consumer Healthcare

Warren, NJ 07059

1-800-897-5623

105282XA

Aquafresh Extra Fresh plus Whitening 5.6oz (158.8g) carton

Principal Display Panel

NDC 0135-0594-01

: Aquafresh®

fluoride toothpaste

triple protection®

WHITENING

MULTI ACTION

Sugar Acid Protection**

from Fluoride

NET WT 5.6 OZ (158.8 g)

cavity protection

healthy gums*

breath

great taste

whitening†

enamel

Invigorating Mint

cavity protection

healthy gums*

fresh breath

great taste

removes surface stains

enamel strengthening

**With Sugar Acid Protection provided by fluoride, which strengthens enamel, creating a shidl that protects the tooth surface against sugar acid attack.

*with twice daily brushing

†whitens by removing surface stains

ALWAYS FOLLOW THE LABEL

Trademarks are owned by or licensed to the GSK group of companies.

GSK Consumer Healthcare

Warren, NJ 07059

105384XA

Aquafresh Multi Action Whitening 5.0 oz (158.8g) carton

Principal Display Panel

NDC 0135-0592-01

: Aquafresh®

fluoride toothpaste

triple protection®

ultimate white

Sugar Acid Protection**

from Fluoride

with whitening action

frost mint

NET WT6.0 OZ (170.1 g)

: Aquafresh® Ultimate White toothpaste gently polishes your teeth, lifts away stains and helps to prevent new stains appearing.
: **With Sugar Acid Protection provided by fluoride, which strengthens enamel, creating a shield that protects the tooth surface against sugar acid attach.

•: healthy gums†
•: strong teeth
•: fresh breath
: †with twice daily brushing

ALWAYS FOLLOW THE LABEL

Trademarks are owned by or licensed to the GSK group of companies.

GSK Consumer Healthcare, Warren, NJ 07059

1-800-897-5623

105287XA

Aquafresh ultimate white 6.0 oz (170.1 g) carton

INGREDIENTS AND APPEARANCE

AQUAFRESH CAVITY PROTECTION

sodium fluoride paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0135-0590
Route of Administration	DENTAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	1.15 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
SORBITOL (UNII: 506T60A25R)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
XANTHAN GUM (UNII: TTV12P4NEE)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
CARRAGEENAN (UNII: 5C69YCD2YJ)
D&C RED NO. 30 (UNII: 2S42T2808B)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Product Characteristics
Color		Score
Shape		Size
Flavor	MINT (cool mint)	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:0135-0590-01	1 in 1 CARTON	10/01/2016
1		158.8 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC:0135-0590-04	2 in 1 CARTON	11/01/2016
2		158.8 g in 1 TUBE; Type 0: Not a Combination Product
3	NDC:0135-0590-02	1 in 1 CARTON	11/01/2016
3		85 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part355	10/01/2016

AQUAFRESH EXTRA FRESH PLUS WHITENING

sodium fluoride paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0135-0591
Route of Administration	DENTAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	1.15 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
SORBITOL (UNII: 506T60A25R)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
XANTHAN GUM (UNII: TTV12P4NEE)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
CARRAGEENAN (UNII: 5C69YCD2YJ)
D&C RED NO. 30 (UNII: 2S42T2808B)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Product Characteristics
Color		Score
Shape		Size
Flavor	MINT (fresh mint)	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:0135-0591-01	1 in 1 CARTON	10/01/2016
1		158.8 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC:0135-0591-02	1 in 1 CARTON	11/01/2016
2		85.1 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part355	05/09/2014

AQUAFRESH MULTI ACTION WHITENING

sodium fluoride paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0135-0594
Route of Administration	DENTAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	1.15 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
SORBITOL (UNII: 506T60A25R)
GLYCERIN (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
XANTHAN GUM (UNII: TTV12P4NEE)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
ZINC CHLORIDE (UNII: 86Q357L16B)
D&C RED NO. 30 (UNII: 2S42T2808B)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Product Characteristics
Color		Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0135-0594-01	1 in 1 CARTON	01/31/2017	06/30/2018
1		158.8 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part355	01/31/2017	06/30/2018

AQUAFRESH ULTIMATE WHITE

sodium fluoride paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0135-0592
Route of Administration	DENTAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	1.1 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
SORBITOL (UNII: 506T60A25R)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM TRIPOLYPHOSPHATE ANHYDROUS (UNII: 9SW4PFD2FZ)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
XANTHAN GUM (UNII: TTV12P4NEE)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
D&C RED NO. 30 (UNII: 2S42T2808B)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Product Characteristics
Color		Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0135-0592-01	1 in 1 CARTON	01/31/2017	08/31/2020
1		170.1 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part355	01/31/2017	08/31/2020

Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)

Revised: 11/2021

Document Id: 406bcedb-ab48-4b75-8e0a-0fa02064deda

Set id: 5484999c-8e6f-430d-99a5-6893a2489467

Version: 7

Effective Time: 20211118

Search by Drug Name or NDC

NDC 00135-0590-04 AQUAFRESH 1.15 mg/g Details

AQUAFRESH 1.15 mg/g

MedlinePlus Drug Summary

Product Information

Package

Package Images

NDC 00135-0590-04 (00135059004)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL 5484999c-8e6f-430d-99a5-6893a2489467 Details

Active ingredient (Cavity Protection, Extra Fresh +Whitening, Multi Action Whitening)

Active ingredient (ultimate white)

Purpose

Use

Warnings

When using this product,

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

Directions

Other information

Inactive ingredients (Cavity Protection)

Inactive ingredients (Extra Fresh +Whitening)

Inactive ingredients (Multi Action Whitening)

Inactive ingredients (ultimate white)

Questions or comments?

Principal Display Panel

Principal Display Panel

Principal Display Panel

Principal Display Panel

INGREDIENTS AND APPEARANCE

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