Dentemp Canker Cover 8ct

Dentemp Canker Cover 8ct
SPL v2
SPL
SPL Set ID 2e7fbf9d-553c-c7bf-e063-6294a90a5f79
Routes
ORAL TOPICAL
Published
Effective Date 2023-02-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (2.5 mg)
Inactive Ingredients
Magnesium Chloride Silicon Dioxide Annatto Carbomer Homopolymer Type A Citrus Limon Fruit Oil Hydroxypropyl Cellulose, Unspecified Povidone K30 Povidone K90 Xylitol

Identifiers & Packaging

Pill Appearance
Shape: round Color: pink Size: 10 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-02-02

Description

Menthol 2.5 mg

Purpose

Ora pain reliever


Medication Information

Purpose

Ora pain reliever

Description

Menthol 2.5 mg

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 53414-9

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

Warnings

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.

Directions

• 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.

Indications

for the temporary relief of pain associated with Canker Sores

8ct Canker Cover

Other Information

store in a cool, dry place.

Inactive Ingredients

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

Questions Or Comments?

833-362-2763 or [email protected]

Active Ingredient (per Each Tablet)

Menthol 2.5 mg


Structured Label Content

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 53414-9 (53414-9)

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

Purpose

Ora pain reliever

Warnings

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.

Directions

• 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.

Indications

for the temporary relief of pain associated with Canker Sores

8ct Canker Cover

Other Information (Other information)

store in a cool, dry place.

Inactive Ingredients (Inactive ingredients)

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

Questions Or Comments? (Questions or comments?)

833-362-2763 or [email protected]

Active Ingredient (per Each Tablet) (Active Ingredient (per each tablet))

Menthol 2.5 mg


Advanced Ingredient Data


Raw Label Data

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