Asutra Relieve Your Pain

Asutra Relieve Your Pain
SPL v1
SPL
SPL Set ID d7c78f30-1c21-1dbb-e053-2995a90a4f64
Route
TOPICAL
Published
Effective Date 2021-04-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (10 g)
Inactive Ingredients
Tridecane Glycerin Pentylene Glycol Alpha-tocopherol Acetate Cetyl Palmitate Arnica Montana Flower Tocopherol Xanthan Gum Potassium Chloride Magnesium Sulfate, Unspecified Form Calcium Chloride Hydroxyacetophenone Sodium Chloride Shea Butter Polyoxyl 20 Cetostearyl Ether Undecane Ascorbyl Palmitate Dimethyl Sulfone Water Magnesium Chloride Glyceryl Stearate Se Almond Oil

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2021-04-29

Description

Menthol USP 10%

Purpose

Menthol USP 10%.....................Topical Analgesic


Medication Information

Purpose

Menthol USP 10%.....................Topical Analgesic

Description

Menthol USP 10%

Uses

For the temporary relief of minor aches and pains of muscles and joints associated with:

  • simple backache
  • arthritis
  • strains
  • bruises
  • sprains
Section 50565-1

Keep out of reach of children. If accidentally ingested, get medical help or contact Poison Control Center immediately.

Section 50566-9

Stop use and ask doctor if:

  • condition worsens
  • symptoms persist for more than 7 days, or clear up and reoccur again within a few days
Section 50567-7

When using this product:

  • avoid contact with eyes and mucous membranes
  • do not apply to wounds or damaged skin
  • do not bandage or use with a heating pad, other ointments, creams, sprays, or liniments.
Section 51945-4

NDC 72683-005-01

Non-toxic

Paraben Free

Asutra*

Relieve

your

pain

10% Menthol

Pain Relief Cream

With Moisturizing

Magnesium and

Arnica Montana

Net Wt. 3.4 oz. | 96 g.

Section 53414-9

If pregnant or breast feeding, ask a health professional before use.

Warnings

Use only as directed. For external use only.

Directions

Adults and children 2 years of age and older:

  • Apply to affected area not more than 3 to 4 times daily.
Other Information
  • Store in a cool, dry place.
  • Avoid direct sunlight.
  • Tamper-evident for your protection. Use only if safety seal is intact.
  • Keep away from excessive heat or flame.
Active Ingredients

Menthol USP 10%

Inactive Ingredients

Aqua, Magnesium Chloride, Dimethyl Sulfone (Methylsulfonylmethane), Glyceryl Stearate SE, Cetearyl Alcohol, Sweet Almond Oil (Prunus Amygdalus Dulcis), Shea Butter (Butyrospermum Parkii), Ceteareth-20, Glycerin, Pentylene Glycol, Undecane, Tocopheryl Acetate, Cetyl Palmitate, Arnica Montana Flower Extract, Tocopherol, Xanthan Gum, Tridecane, Sodium Chloride, Potassium Chloride, Magnesium Sulfate, Calcium Chloride, Ascorbyl Palmitate, Hydroxyacetophenone

Questions Or Comments?

888-819-6472; Monday-Friday, 9am-5pm CT

Report any serious side effects to number above.


Structured Label Content

Uses

For the temporary relief of minor aches and pains of muscles and joints associated with:

  • simple backache
  • arthritis
  • strains
  • bruises
  • sprains
Section 50565-1 (50565-1)

Keep out of reach of children. If accidentally ingested, get medical help or contact Poison Control Center immediately.

Section 50566-9 (50566-9)

Stop use and ask doctor if:

  • condition worsens
  • symptoms persist for more than 7 days, or clear up and reoccur again within a few days
Section 50567-7 (50567-7)

When using this product:

  • avoid contact with eyes and mucous membranes
  • do not apply to wounds or damaged skin
  • do not bandage or use with a heating pad, other ointments, creams, sprays, or liniments.
Section 51945-4 (51945-4)

NDC 72683-005-01

Non-toxic

Paraben Free

Asutra*

Relieve

your

pain

10% Menthol

Pain Relief Cream

With Moisturizing

Magnesium and

Arnica Montana

Net Wt. 3.4 oz. | 96 g.

Section 53414-9 (53414-9)

If pregnant or breast feeding, ask a health professional before use.

Purpose

Menthol USP 10%.....................Topical Analgesic

Warnings

Use only as directed. For external use only.

Directions

Adults and children 2 years of age and older:

  • Apply to affected area not more than 3 to 4 times daily.
Other Information
  • Store in a cool, dry place.
  • Avoid direct sunlight.
  • Tamper-evident for your protection. Use only if safety seal is intact.
  • Keep away from excessive heat or flame.
Active Ingredients

Menthol USP 10%

Inactive Ingredients

Aqua, Magnesium Chloride, Dimethyl Sulfone (Methylsulfonylmethane), Glyceryl Stearate SE, Cetearyl Alcohol, Sweet Almond Oil (Prunus Amygdalus Dulcis), Shea Butter (Butyrospermum Parkii), Ceteareth-20, Glycerin, Pentylene Glycol, Undecane, Tocopheryl Acetate, Cetyl Palmitate, Arnica Montana Flower Extract, Tocopherol, Xanthan Gum, Tridecane, Sodium Chloride, Potassium Chloride, Magnesium Sulfate, Calcium Chloride, Ascorbyl Palmitate, Hydroxyacetophenone

Questions Or Comments? (Questions or Comments?)

888-819-6472; Monday-Friday, 9am-5pm CT

Report any serious side effects to number above.


Advanced Ingredient Data


Raw Label Data

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