OTC Medication Information: Enamel Defense

ENAMEL DEFENSE- sodium fluoride paste, dentifrice
Church & Dwight Co., 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.

Sodium Fluoride 0.24%

Anticavity toothpaste

Use

aids in the prevention of dental decay

Warnings

Do not use if irritation occurs and persists.

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

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

Directions

  • do not swallow
  • supervise children as necessary until capable of using without supervision
  • rinse away toothpaste residue thoroughly after brushing

adults and children 2 years and older — brush teeth thoroughly after meals or at least twice a day, or use as directed by a dentist or physician

children under 6 years — instruct in good brushing and rinsing habits (to minimize swallowing)

children under 2 years — ask a dentist or physician

sodium bicarbonate (baking soda), PEG-8, hydrated silica, glycerin, calcium sulfate, sodium lauryl sulfate, sodium saccharin, flavor, dipotassium phosphate, PEG/PPG 116/66 copolymer, sodium carbonate, calcium peroxide, mica, titanium dioxide

Questions or comments? Call 1-800-786-5135 Mon.-Fri. 9am-5pm ET or visit www.myoralcare.com

ARM & HAMMER

THE STANDARD OF PURITY

Enamel Defense

Fluoride Anticavity Toothpaste

formerly known as BRIGHT & STRONG

REPAIRS AND PROTECTS ENAMEL SURFACE

Crisp Mint

NET WT 4.3 OZ. (121g)

LO_S01686C_2048783_R6
(click image for full-size original)
ENAMEL DEFENSE
sodium fluoride paste, dentifrice
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:10237-666
Route of Administration DENTAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SODIUM FLUORIDE (FLUORIDE ION) FLUORIDE ION 0.24 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
METHYL SALICYLATE
MICA
POLYETHYLENE GLYCOL 400
SODIUM LAURYL SULFATE
GLYCERIN
SODIUM BICARBONATE
HYDRATED SILICA
CALCIUM SULFATE
SACCHARIN SODIUM
POTASSIUM PHOSPHATE, DIBASIC
PEG/PPG-116/66 COPOLYMER
SODIUM CARBONATE
CALCIUM PEROXIDE
TITANIUM DIOXIDE
Product Characteristics
Color white Score
Shape Size
Flavor MINT (Crisp Mint) Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:10237-666-43 1 TUBE in 1 CARTON contains a TUBE
1 121 g in 1 TUBE This package is contained within the CARTON (10237-666-43)
2 NDC:10237-666-09 1 TUBE in 1 CARTON contains a TUBE
2 25 g in 1 TUBE This package is contained within the CARTON (10237-666-09)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part355 04/01/2020
Labeler — Church & Dwight Co., Inc. (001211952)
Establishment
Name Address ID/FEI Operations
Church & Dwight Co., Inc. 043690812 manufacture (10237-666)

Revised: 04/2020 Church & Dwight Co., Inc.

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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