FDA Label for Orajle Anti-bacterial Rinse For Bleeding Gums
View Indications, Usage & Precautions
Orajle Anti-bacterial Rinse For Bleeding Gums Product Label
The following document was submitted to the FDA by the labeler of this product Church & Dwight Co., Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Otc - Active Ingredient
Active ingredient Purpose
Cetylpyridinium chloride 0.1% Antigingivitis/Antiplaque
Otc - Purpose
Uses
helps prevent plaque that leads to
gingivitis
bleeding gums
Warnings
Warnings
When using this product do not swallow
Stop use and ask a dentist if
- gingivitis, bleeding or redness persists for 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 or symptoms 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 right away
Otc - When Using
Directions remove imprinted safety seal from bottle cap; to remove child-resistant cap, squeeze smooth sides of cap while turning. Reclose tightly.
Adults and children Vigorously swish 20 milliliters of rinse between your teeth
6 years of age and older twice a day for 30 seconds and then spit out. Do not swallow the rinse
Children 6 years to under Supervise use
12 years of age
Children under 6 years of age Do not use
Other information this rinse is not intended to replace brushing or flossing ; cap tightly; keep away from heat or direct sunlight; do not use if safety seal is broken or missing.
Inactive ingredients alcohol (14.2% by volume), disodium phosphate, flavor, green 5, poloxamer 407, purified water, sodium phosphate, sodium saccharin, sorbitol, yellow 5
Otc - Questions
Questions or comments? call us at 1-800-952-5080 M-F 9am-5pm ET or visit our website at www.orajel.com
Package Label.Principal Display Panel
Orajel Anti-Bacterial Rinse
for Bleeding Gums 16 oz.
Label image
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