cariba 664.003/664at rev 2/au

cariba 664.003/664at rev 2/au
SPL v16
SPL
SPL Set ID 035e82fc-75eb-474d-88ce-771e60e62179
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 benzoate fd&c green no. 3

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2016-11-08

Adverse Reactions

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

Purpose

Antigingivitis, Antiplaque

Description

Sealed With Printed Neckband For Your Protection


Medication Information

Warnings

for this product

Purpose

Antigingivitis, Antiplaque

Directions

adults and children 12 years of age and older - vigorously swish 20 mL (2/3 FL OZ or 4 teaspoonfuls) 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
Adverse Reactions

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).

Inactive Ingredients

water, alcohol 21.6%, sorbitol, poloxamer 407, benzoic acid, sodium saccharin, sodium benzoate, flavor, green 3

Description

Sealed With Printed Neckband For Your Protection

Principal Display Panel

CARIBA

CARE

ANTISEPTIC

Mouthwash

ANTIGINGIVIS/ANTIPLAQUE

BLUE MINT

Kills germs that cause Bad Breath, Plaque & the gum disease Gingivitis

1 L (33.8 FL OZ) 1.05 QT

Use

helps control plaque that leads to gingivitis

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.

Active Ingredients

Eucalyptol 0.092%

Menthol 0.042%

Methyl salicylate 0.060%

Thymol 0.064%

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

Warnings

for this product

Purpose

Antigingivitis, Antiplaque

Directions

adults and children 12 years of age and older - vigorously swish 20 mL (2/3 FL OZ or 4 teaspoonfuls) 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
Adverse Reactions

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).

Inactive Ingredients (Inactive ingredients)

water, alcohol 21.6%, sorbitol, poloxamer 407, benzoic acid, sodium saccharin, sodium benzoate, flavor, green 3

Principal Display Panel (principal display panel)

CARIBA

CARE

ANTISEPTIC

Mouthwash

ANTIGINGIVIS/ANTIPLAQUE

BLUE MINT

Kills germs that cause Bad Breath, Plaque & the gum disease Gingivitis

1 L (33.8 FL OZ) 1.05 QT

Use

helps control plaque that leads to gingivitis

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.

Active Ingredients (Active ingredients)

Eucalyptol 0.092%

Menthol 0.042%

Methyl salicylate 0.060%

Thymol 0.064%

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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