Cariba 072.003/072al-an

Cariba 072.003/072al-an
SPL v14
SPL
SPL Set ID 4ca91b34-a3ba-4c23-8bfb-473342ac42a2
Route
ORAL
Published
Effective Date 2025-07-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Eucalyptol (0.92 mg) Menthol (0.42 mg) Salicylic Acid (0.6 mg) Thymol (0.64 mg)
Inactive Ingredients
Water Alcohol Sorbitol Poloxamer 407 Benzoic Acid Saccharin Sodium Sodium Citrate D&c Yellow No. 10 Fd&c Green No. 3

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2016-11-18

Description

Sealed With Printed Neckband For Your Protection

Purpose

Antigingivitis, Antiplaque


Medication Information

Purpose

Antigingivitis, Antiplaque

Description

Sealed With Printed Neckband For Your Protection

Use

Helps control plaque that leads to gingivitis

Warnings

for this product

Directions

adults and and children 12 years of age and older - vigorously swish 20 mL (2/3 FL OZ or 4 teaspoonful) between teeth twice a day for 30 seconds then spit out; do not swallow

children under 12 years of age -  consult a dentist or doctor

  • this rinse is not intended to replace brushing or flossing
Do Not Use

if you have painful or swollen gums, pus from the gum line, loose teeth or increased spacing between the teeth.  See your dentist immediately.  These may be signs of periodontitis, a serious form of gum disease.

Adverse Reaction

Distributed by:

Cariba International

P.O. Box 1208

Safety Harbor, Florida 34695

MADE IN USA WITH US AND FOREIGN COMPONENTS

DSP-TN-21091 DSP-MO-20087

Other Information

cold weather may cloud this product. Its antiseptic properties are not affected. Store at room temperature (59° -77°F).

Active Ingredients

Eucalyptol 0.092%

Menthol 0.042%

Methyl sailcylate 0.060%

Thymol 0.064%

Inactive Ingredients

water, alcohol 21.6%, sorbitol, poloxamer 407, benzoic acid, sodium saccharin, flavor, sodium citrate, yellow 10, green 3

Principal Display Panel

CARIBA CARE

ANTISEPTIC

Mouthwash

Antigingivitis/Antiplaque

Fresh Mint

Kills germs that cause bad breath, plaque & the gum disease gingivitis

1 L (33.8 FL OZ) 1.05 QT

Tamper Evident Statement

Sealed With Printed Neckband For Your Protection

Stop Use and Ask A Dentist If

gingivitis, bleeding, or redness persists for more than 2 weeks

Keep Out of Reach of Children.

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


Structured Label Content

Use

Helps control plaque that leads to gingivitis

Purpose

Antigingivitis, Antiplaque

Warnings

for this product

Directions

adults and and children 12 years of age and older - vigorously swish 20 mL (2/3 FL OZ or 4 teaspoonful) between teeth twice a day for 30 seconds then spit out; do not swallow

children under 12 years of age -  consult a dentist or doctor

  • this rinse is not intended to replace brushing or flossing
Do Not Use (Do not use)

if you have painful or swollen gums, pus from the gum line, loose teeth or increased spacing between the teeth.  See your dentist immediately.  These may be signs of periodontitis, a serious form of gum disease.

Adverse Reaction (ADVERSE REACTION)

Distributed by:

Cariba International

P.O. Box 1208

Safety Harbor, Florida 34695

MADE IN USA WITH US AND FOREIGN COMPONENTS

DSP-TN-21091 DSP-MO-20087

Other Information (Other information)

cold weather may cloud this product. Its antiseptic properties are not affected. Store at room temperature (59° -77°F).

Active Ingredients (Active ingredients)

Eucalyptol 0.092%

Menthol 0.042%

Methyl sailcylate 0.060%

Thymol 0.064%

Inactive Ingredients (Inactive ingredients)

water, alcohol 21.6%, sorbitol, poloxamer 407, benzoic acid, sodium saccharin, flavor, sodium citrate, yellow 10, green 3

Principal Display Panel (Principal display panel)

CARIBA CARE

ANTISEPTIC

Mouthwash

Antigingivitis/Antiplaque

Fresh Mint

Kills germs that cause bad breath, plaque & the gum disease gingivitis

1 L (33.8 FL OZ) 1.05 QT

Tamper Evident Statement

Sealed With Printed Neckband For Your Protection

Stop Use and Ask A Dentist If (Stop use and ask a dentist if)

gingivitis, bleeding, or redness persists for more than 2 weeks

Keep Out of Reach of Children. (Keep out of reach of children.)

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


Advanced Ingredient Data


Raw Label Data

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