H E B Restore and Defend: Package Insert and Label Information

H E B RESTORE AND DEFEND- stannous fluoride paste, dentifrice
HEB

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.

Drug Facts

Active ingredients

Stannous Fluoride 0.454% (0.15% w/v fluoride ion)

Purpose

Anticavity/Antihypersensitivity

Uses

  • aids in the prevention of dental cavities
  • builds increasing protection against painful sensitivity of the teeth to cold, heat, acids sweets or contact

Warnings

When using this product, if irritation occurs discontinue use.

Stop use and ask a dentist if:

  • the problem persists or worsens. Sensitive teeth may indicate a serious problem that may need prompt care by a dentist.
  • pain/sensitivity still persists after 4 weeks of use

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

Directions

Adults and children 12 years of age and older: Apply at least a 1-inch strip of the product onto a soft bristle toothbrush.

  • Brush teeth thoroughly for at least one minute, preferably after each meal or at least twice a day (morning and evening) or as directed by a dentist or physician. Make sure to brush all sensitive areas of the teeth.
  • Do not swallow.
  • Children under 12 years of age: consult a dentist or doctor.

Other information

products containing stannous fluoride may produce surface staining of the teeth. Adequate brushing may prevent these stains which are not harmful or permanent and may be removed by your dentist.

  • This product is specifically formulated to help prevent staining.
  • store below 30°C (86°)F

Inactive ingredients water, glycerin, hydrated silica, sodium tripolyphosphate, sodium saccharin, titanium dioxide, cellulose gum, cocamidopropyl betaine, sodium lauryl sulfate, flavor

Questions or Comments? CALL 1-877-777-2743

MADE WITH PRIDE AND CARE FOR H-E-B®

SAN ANTONIO, TX 78204

H-E-B®

Fresh Mint

SENSITIVE

FLUORIDE TOOTHPASTE FOR SENSITIVE TEETH & CAVITY PROTECTION

RESTORE & DEFEND

  • Daily protection for sensitive teeth
  • Removes stains for whiter teeth

TWIN PACK

2 Tubes of 3.4 OZ (96.3g); TOTAL NET WT. 6.8 OZ (192.6g)

HEB RESTORE DEFEND 2PK 2821273R1
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H E B RESTORE AND DEFEND
fluoride paste, dentifrice
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:37808-230
Route of Administration DENTAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
STANNOUS FLUORIDE (FLUORIDE ION) FLUORIDE ION 0.15 g in 100 g
Inactive Ingredients
Ingredient Name Strength
SORBITOL
GLYCERIN
SACCHARIN SODIUM
WATER
TITANIUM DIOXIDE
SODIUM TRIPOLYPHOSPHATE ANHYDROUS
CARBOXYMETHYLCELLULOSE SODIUM
COCAMIDOPROPYL BETAINE
SODIUM LAURYL SULFATE
HYDRATED SILICA
Product Characteristics
Color white Score
Shape Size
Flavor MINT Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:37808-230-09 1 TUBE in 1 CARTON contains a TUBE
1 96.4 g in 1 TUBE This package is contained within the CARTON (37808-230-09)
2 NDC:37808-230-92 2 TUBE in 1 CARTON contains a TUBE
2 96.4 g in 1 TUBE This package is contained within the CARTON (37808-230-92)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part356 07/01/2014
Labeler — HEB (007924756)
Registrant — Lornamead Inc. (080046418)
Establishment
Name Address ID/FEI Operations
Lornamead Inc. 080046418 manufacture (37808-230)

Revised: 06/2020 HEB

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