Ndc 59088-794 Diabecin Cs Cream

Ndc 59088-794 Diabecin Cs Cream
SPL v1
SPL
SPL Set ID 33ef2233-7a66-ee65-e063-6294a90ac55a
Route
TOPICAL
Published
Effective Date 2025-04-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Capsaicin (0.0005 g) Menthol (0.02 g)
Inactive Ingredients
Dimethicone Lecithin, Soybean Nylon-12 Peucedanum Ostruthium Leaf Sodium Hyaluronate Laureth-7 Carthamus Tinctorius (safflower) Oleosomes Peg-100 Stearate Sodium Ascorbyl Phosphate Polyacrylamide (1500 Mw) Silica Water Arnica Montana Flower Glyceryl Stearate C12-15 Alkyl Benzoate Glycerin Myristyl Myristate Ginger Cetearyl Alcohol Imidazolidinyl Urea .alpha.-tocopherol Acetate, Dl- Bisabolol Calendula Officinalis Flower Isopropyl Myristate Maltodextrin Niacinamide Phenoxyethanol Chamomile Escin Aluminum Starch Octenylsuccinate Beta-sitosterol Pyridoxine Hcl Aloe Barbadensis Leaf Juice C13-14 Isoparaffin Calcium Pantothenate Ginkgo Biloba Leaf

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-06-10

Description

Menthol 2% Capsaicin 0.05%

Purpose

Menthol -Topical Analgesic Capsaicin- Topical Analgesic


Medication Information

Purpose

Menthol -Topical Analgesic

Capsaicin- Topical Analgesic

Description

Menthol 2% Capsaicin 0.05%

Uses

For the temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises, and sprains.

Warnings

For external use only

• This is not a face cream. Do not apply to the face.

• Do not use at the same time with other topical analgesics.

• Do not use if allergic to chili peppers or if past allergic reaction to capsaicin.

• Do not apply to wounds or damaged skin.

• Do not bandage tightly.

• Do not apply within 1 hour before or after bath, shower, hot tub, sauna, or vigorous exercise. Warm water, perspiration, or open pores can intensify the impact of this product and burning sensation.

• Do not use with heating pad, hot water bottle or other source of heat. Doing so can increase risk of serious burn.

Directions

• Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily. Children under 2 years of age: do not use, consult a doctor.

• Apply sparingly to affected area not more than 4 times daily. However, for first use, apply to small area to test for sensitivity or skin reaction.

• Gently massage into the skin until fully absorbed.

• Wash hands with soap and water thoroughly after each application to avoid spreading to the eyes or other sensitive mucous membranes.

Active Ingredient

Menthol 2%

Capsaicin 0.05%

Other Information

Store in a cool well-ventilated area away from heat. Keep away from sparks or open flame. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Avoid excessive heat. Do not use if package is damaged.

Diabecin Cs™ Cream

Manufactured by:

PureTek Corporation

Panorama City, CA 91402

For questions or information

call toll-free: 877-921-7873

Inactive Ingredients:

Aloe Barbadensis (Aloe Vera) Leaf Juice, Aqua (Purified Water), Arnica Montana (Arnica) Flower Extract, Beta-Sitosterol, Bisabolol, C12-15 Alkyl Benzoate, C13-14 Isoparaffin, Calcium Pantothenate (Vitamin B5), Calendula Officinalis (Calendula) Flower Extract, Carthamus Tinctorius (Safflower) Oleosomes, Cetearyl Alcohol, Chamomilla Recutita (Matricaria) Flower Extract, Dimethicone, DL-Alpha-Tocopheryl Acetate (Vitamin E), Escin, Ginkgo Biloba (Ginkgo) Leaf Extract, Glycerin, Glyceryl Stearate, Imidazolidinyl Urea, Isopropyl Myristate, Laureth-7, Lecithin, Maltodextrin, Myristyl Myristate, Niacinamide (Vitamin B3), Nylon-12, PEG-100 Stearate, Peucedanum Ostruthium (Masterwort) Leaf Extract, Phenoxyethanol, Polyacrylamide, Pyridoxine HCl (Vitamin B6), Silica, Sodium Ascorbyl Phosphate (Vitamin C), Sodium Hyaluronate, Sodium Starch Octenylsuccinate, Zingiber Officinale (Ginger) Root Extract.

When Using This Product

• Avoid contact with the eyes.

Stop Use and Ask A Doctor If

• condition worsens • symptoms last more than 7 days or clear up and occur again within a few days

Keep Out of Reach of Children.

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


Structured Label Content

Uses

For the temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises, and sprains.

Purpose

Menthol -Topical Analgesic

Capsaicin- Topical Analgesic

Warnings

For external use only

• This is not a face cream. Do not apply to the face.

• Do not use at the same time with other topical analgesics.

• Do not use if allergic to chili peppers or if past allergic reaction to capsaicin.

• Do not apply to wounds or damaged skin.

• Do not bandage tightly.

• Do not apply within 1 hour before or after bath, shower, hot tub, sauna, or vigorous exercise. Warm water, perspiration, or open pores can intensify the impact of this product and burning sensation.

• Do not use with heating pad, hot water bottle or other source of heat. Doing so can increase risk of serious burn.

Directions

• Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily. Children under 2 years of age: do not use, consult a doctor.

• Apply sparingly to affected area not more than 4 times daily. However, for first use, apply to small area to test for sensitivity or skin reaction.

• Gently massage into the skin until fully absorbed.

• Wash hands with soap and water thoroughly after each application to avoid spreading to the eyes or other sensitive mucous membranes.

Active Ingredient (Active ingredient)

Menthol 2%

Capsaicin 0.05%

Other Information (Other information)

Store in a cool well-ventilated area away from heat. Keep away from sparks or open flame. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Avoid excessive heat. Do not use if package is damaged.

Diabecin Cs™ Cream (Diabecin CS™ Cream)

Manufactured by:

PureTek Corporation

Panorama City, CA 91402

For questions or information

call toll-free: 877-921-7873

Inactive Ingredients: (Inactive ingredients:)

Aloe Barbadensis (Aloe Vera) Leaf Juice, Aqua (Purified Water), Arnica Montana (Arnica) Flower Extract, Beta-Sitosterol, Bisabolol, C12-15 Alkyl Benzoate, C13-14 Isoparaffin, Calcium Pantothenate (Vitamin B5), Calendula Officinalis (Calendula) Flower Extract, Carthamus Tinctorius (Safflower) Oleosomes, Cetearyl Alcohol, Chamomilla Recutita (Matricaria) Flower Extract, Dimethicone, DL-Alpha-Tocopheryl Acetate (Vitamin E), Escin, Ginkgo Biloba (Ginkgo) Leaf Extract, Glycerin, Glyceryl Stearate, Imidazolidinyl Urea, Isopropyl Myristate, Laureth-7, Lecithin, Maltodextrin, Myristyl Myristate, Niacinamide (Vitamin B3), Nylon-12, PEG-100 Stearate, Peucedanum Ostruthium (Masterwort) Leaf Extract, Phenoxyethanol, Polyacrylamide, Pyridoxine HCl (Vitamin B6), Silica, Sodium Ascorbyl Phosphate (Vitamin C), Sodium Hyaluronate, Sodium Starch Octenylsuccinate, Zingiber Officinale (Ginger) Root Extract.

When Using This Product (When using this product)

• Avoid contact with the eyes.

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

• condition worsens • symptoms last more than 7 days or clear up and occur again within a few days

Keep Out of Reach of Children. (Keep out of reach of children.)

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


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