Cariba 318.003/318ah-ai

SPL v15

SPL

SPL Set ID 98471185-3798-412f-b9b4-47f1971fbc7c

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 Benzoic Acid Poloxamer 407 Sodium Benzoate Caramel

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2016-11-07

Description

Sealed With Printed Neckband For Your Protection

Purpose

Antigingivitis, Antiplaque

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

Medication Information

Purpose

Antigingivitis, Antiplaque

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

Description

Sealed With Printed Neckband For Your Protection

Use

Helps control plaque that leads to gingivitis

Warnings

for this product

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

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.

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 salicylate 0.060%

Thymol 0.064%

Inactive Ingredients

water, alcohol 26.9%, benzoic acid, poloxamer 407, sodium benzoate, caramel

Principal Display Panel

CARIBA

CARE

ANTISEPTIC

MOUTHWASH

ANTIGINGIVITIS/ANTIPLAQUE

ORIGINAL

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 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

Do Not Use (Do not use)

Adverse Reactions (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).

Active Ingredients (Active ingredients)

Eucalyptol 0.092%

Menthol 0.042%

Methyl salicylate 0.060%

Thymol 0.064%

Inactive Ingredients (Inactive ingredients)

water, alcohol 26.9%, benzoic acid, poloxamer 407, sodium benzoate, caramel

Principal Display Panel (Principal display panel)

CARIBA

CARE

ANTISEPTIC

MOUTHWASH

ANTIGINGIVITIS/ANTIPLAQUE

ORIGINAL

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

[{"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ALCOHOL", "unii": "3K9958V90M", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "BENZOIC ACID", "unii": "8SKN0B0MIM", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLOXAMER 407", "unii": "TUF2IVW3M2", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM BENZOATE", "unii": "OJ245FE5EU", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CARAMEL", "unii": "T9D99G2B1R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "EUCALYPTOL", "unii": "RV6J6604TK", "classCode": "ACTIB", "strengthNumerator": "0.92", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "MENTHOL", "unii": "L7T10EIP3A", "classCode": "ACTIB", "strengthNumerator": "0.42", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "SALICYLIC ACID", "unii": "O414PZ4LPZ", "classCode": "ACTIB", "strengthNumerator": "0.6", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "THYMOL", "unii": "3J50XA376E", "classCode": "ACTIB", "strengthNumerator": "0.64", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}]

Raw Label Data

All Sections (JSON)

{"Use": "Helps control plaque that leads to gingivitis", "Purpose": "Antigingivitis, Antiplaque", "Warnings": "for this product", "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", "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 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).", "Active ingredients": "Eucalyptol 0.092% Menthol 0.042% Methyl salicylate 0.060% Thymol 0.064%", "Inactive ingredients": "water, alcohol 26.9%, benzoic acid, poloxamer 407, sodium benzoate, caramel", "Principal display panel": "CARIBA CARE ANTISEPTIC MOUTHWASH ANTIGINGIVITIS/ANTIPLAQUE ORIGINAL 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."}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:08:28.960156 · Updated: 2026-03-14T23:12:42.073607