Comfortox B

Comfortox B
SPL v6
SPL
SPL Set ID cfb3cb1f-255f-4319-98bb-c353cc0be00e
Route
TOPICAL
Published
Effective Date 2022-01-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzocaine (20 mg)
Inactive Ingredients
Water Arnica Montana Flower C13-14 Isoparaffin Medium-chain Triglycerides Ceteareth-25 Chondroitin Sulfate Sodium (bovine) Docusate Sodium Emu Oil Diethylene Glycol Monoethyl Ether Ethylhexylglycerin Glucosamine Sulfate Glycerin Isopropyl Palmitate Laureth-7 Melaleuca Alternifolia Leaf Dimethyl Sulfone Phenoxyethanol Polyacrylamide (10000 Mw) Polysorbate 20 Safflower Oil Stearic Acid Trolamine

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2016-09-07

Description

Benzocaine     20.0% w/w

Purpose

External Analgesic


Medication Information

Purpose

External Analgesic

Description

Benzocaine     20.0% w/w

Section 50565-1

​Keep out of reach of children

• If product is swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9

​Stop use and ask doctor if

• Condition worsens, or if symptoms persist for more then 7 days or clear up and occur again within a few days.  Discontinue use.

Section 51945-4

​uses

For temporary relief of pain and itching due to minor skin irritation.

​purpose

External Analgesic

​warnings

​For external use only

Avoid contact with eyes

​directions

For adults and children two-years or older: Apply to affected area not more then 3 or 4 times daily.  Children under 2 years of age: consult a physician.

​other Information

Protect this product from excessive heat or direct sun.

​active Ingredients

Benzocaine     20.0% w/w

​inactive Ingredients

Aqua (Deionized Water), Arnica Montana Flower Extract, C13-14 Isoparaffin, Caprylic/Capric Triglyceride, Cetearetj-25, Chondroitin Sulfate, Diethylhexyl Sodium Sulfosuccinate, Emu Oil, Ethoxydiglycol, Ethylhexylglycerin, Glucosamine Sulfate, Glycerin, Isopropyl Palmitate, Laureth-7, Melaleuca alternifolia (Tea Tree) Leaf Oil, Methylfulfonylmenthane (MSM), Phenoxyethanol, Polyacrylamide, Polysorbate-20, Safflower Oil, Stearic Acid, Triethanolamine

​questions Or Comments?

FDA Registered: NDC No. 54723-999-01

800-693-9067


Structured Label Content

Section 50565-1 (50565-1)

​Keep out of reach of children

• If product is swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9 (50566-9)

​Stop use and ask doctor if

• Condition worsens, or if symptoms persist for more then 7 days or clear up and occur again within a few days.  Discontinue use.

Section 51945-4 (51945-4)

​uses (​Uses)

For temporary relief of pain and itching due to minor skin irritation.

​purpose (​Purpose)

External Analgesic

​warnings (​Warnings)

​For external use only

Avoid contact with eyes

​directions (​Directions)

For adults and children two-years or older: Apply to affected area not more then 3 or 4 times daily.  Children under 2 years of age: consult a physician.

​other Information (​Other Information)

Protect this product from excessive heat or direct sun.

​active Ingredients (​Active Ingredients)

Benzocaine     20.0% w/w

​inactive Ingredients (​Inactive Ingredients)

Aqua (Deionized Water), Arnica Montana Flower Extract, C13-14 Isoparaffin, Caprylic/Capric Triglyceride, Cetearetj-25, Chondroitin Sulfate, Diethylhexyl Sodium Sulfosuccinate, Emu Oil, Ethoxydiglycol, Ethylhexylglycerin, Glucosamine Sulfate, Glycerin, Isopropyl Palmitate, Laureth-7, Melaleuca alternifolia (Tea Tree) Leaf Oil, Methylfulfonylmenthane (MSM), Phenoxyethanol, Polyacrylamide, Polysorbate-20, Safflower Oil, Stearic Acid, Triethanolamine

​questions Or Comments? (​Questions or Comments?)

FDA Registered: NDC No. 54723-999-01

800-693-9067


Advanced Ingredient Data


Raw Label Data

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