dentemp canker cover 2ct

dentemp canker cover 2ct
SPL v2
SPL
SPL Set ID 2b4b22e9-a03b-fb8f-e063-6394a90a8747
Routes
topical oral
Published
Effective Date 2025-01-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
menthol (2.5 mg)
Inactive Ingredients
magnesium chloride xylitol silicon dioxide povidone k90 carbomer homopolymer type a citrus limon fruit oil hydroxypropyl cellulose, unspecified annatto povidone k30

Identifiers & Packaging

Pill Appearance
Shape: round Color: pink Size: 10 mm Score: 1
Marketing Status
otc monograph drug active Since 2025-01-09

Description

Menthol 2.5 mg


Medication Information

Warnings and Precautions

Do not use this product for more than 7 days unless directed by a dentist or doctor. Stop use and ask a dentist or doctor if • sore mouth symptoms do not improve in 7 days • irritation, pain or redness worsens • swelling, rash or fever develops.

Do not exceed recommended dosage.

Active Ingredient

Menthol 2.5 mg

Indications and Usage

For temporary relief of pain associated with Canker Sores

Dosage and Administration

adults and children 5 years of age and older, apply up to 3 tablets a day, as needed. Place the tablet on a clean, dry finger with the white side up. Place the white side on the sore and hold in place for 10 seconds. If sore is difficult to reach (in the fold between the cheek and gum or near the teeth or lip) break the tablet along the score and use half. Some discomfort may occur during the first few minutes, but will quickly subside, followed by hours of soothing relief. Within 30 minutes, the tablet forms a clear, gel-like bandage that seals and protects the sore for hours before dissolving. Do not remove the tablet before it dissolves. In case of discomfort, the tablet may be removed by gently peeling the tablet from the sides while washing with warm water. Do not use any instrument to remove the tablet. • children under 5 years, ask a doctor.

Description

Menthol 2.5 mg

Section 44425-7

store in a cool, dry place.

Section 50565-1

Keep out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Section 51727-6

annatto, carbomer homopolymer type a, citrus oil, hydroxypropyl cellulose, magnesium chloride, povidone K30, povidone K90, silicon dioxide, xylitol

Section 51945-4

Section 53413-1

833-362-2763 or [email protected]

Section 53414-9

If pregnant or breastfeeding or taking prescription drugs, ask a health care professional before use.

Section 55105-1

Oral Pain Reliever


Structured Label Content

Warnings and Precautions (34071-1)

Do not use this product for more than 7 days unless directed by a dentist or doctor. Stop use and ask a dentist or doctor if • sore mouth symptoms do not improve in 7 days • irritation, pain or redness worsens • swelling, rash or fever develops.

Do not exceed recommended dosage.

Active Ingredient (55106-9)

Menthol 2.5 mg

Indications and Usage (34067-9)

For temporary relief of pain associated with Canker Sores

Dosage and Administration (34068-7)

adults and children 5 years of age and older, apply up to 3 tablets a day, as needed. Place the tablet on a clean, dry finger with the white side up. Place the white side on the sore and hold in place for 10 seconds. If sore is difficult to reach (in the fold between the cheek and gum or near the teeth or lip) break the tablet along the score and use half. Some discomfort may occur during the first few minutes, but will quickly subside, followed by hours of soothing relief. Within 30 minutes, the tablet forms a clear, gel-like bandage that seals and protects the sore for hours before dissolving. Do not remove the tablet before it dissolves. In case of discomfort, the tablet may be removed by gently peeling the tablet from the sides while washing with warm water. Do not use any instrument to remove the tablet. • children under 5 years, ask a doctor.

Section 44425-7 (44425-7)

store in a cool, dry place.

Section 50565-1 (50565-1)

Keep out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Section 51727-6 (51727-6)

annatto, carbomer homopolymer type a, citrus oil, hydroxypropyl cellulose, magnesium chloride, povidone K30, povidone K90, silicon dioxide, xylitol

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

833-362-2763 or [email protected]

Section 53414-9 (53414-9)

If pregnant or breastfeeding or taking prescription drugs, ask a health care professional before use.

Section 55105-1 (55105-1)

Oral Pain Reliever


Advanced Ingredient Data


Raw Label Data

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