Acclean 60 Second Fluoride Treatment

Name: Acclean 60 Second Fluoride Treatment

Storage

Store at room temperature

Information in French and Barcode

Main Panel

ACCLEAN  60 SECOND FLUORIDE TREATMENT
fluoride gel
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0404-3963
Route of Administration DENTAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SODIUM FLUORIDE (FLUORIDE ION) FLUORIDE ION 0.0272 g  in 1 mL
Product Characteristics
Color pink Score     
Shape Size
Flavor BUBBLE GUM Imprint Code
Contains     
Packaging
# Item Code Package Description
1 NDC:0404-3963-03 12 BOTTLE, PLASTIC in 1 CASE
1 NDC:0404-3963-01 480 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 03/03/2017
Labeler - Henry Schein Inc. (012430880)
Revised: 03/2017   Henry Schein Inc.

For the Consumer

Applies to fluoride topical: dental cream, dental gel, dental paste, mouth/throat concentrate, mouth/throat liquid, mouth/throat paste, mouth/throat solution

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Very upset stomach or throwing up.

Fluoride topical Breastfeeding Warnings

There are no data on the excretion of fluoride into human milk. Because many drugs are excreted in milk, caution is recommended if products containing fluoride are administered to a nursing woman.

Reduced milk production was reported in farm-raised animals when they were fed a diet containing a high concentration of fluoride (98 to 137 mg/kg of body weight). No adverse effects on parturition, lactation, or offspring were seen in animals administered fluoride up to 5 mg/kg of body weight.

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