Melt Pain Away (asutra)

Melt Pain Away (asutra)
SPL v3
SPL
SPL Set ID a95a11d7-a2ae-6654-e053-2a95a90a802c
Route
TOPICAL
Published
Effective Date 2020-04-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Capsaicin (0.025 g)
Inactive Ingredients
Cetostearyl Alcohol Sodium Lactate Cetyl Palmitate Polyglyceryl-3 Distearate Magnesium Sulfate, Unspecified Hydroxyacetophenone Panthenol Sodium Hydroxide Cymbopogon Flexuosus Leaf Pentaerythritol Tetrakis(3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate) Magnesium Chloride Shea Butter Dimethyl Sulfone Glyceryl Stearate Citrate Glycerin Glyceryl Stearate Se Undecane Xanthan Gum Tridecane Potassium Chloride Calcium Chloride .alpha.-tocopherol Acetate Almond Oil Pentylene Glycol Sodium Chloride Allantoin Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-04-15

Description

Capsaicin .025%


Medication Information

Warnings and Precautions

Use only as directed.

For external use only.

Indications and Usage

Temporarily relieves minor aches and pains of muscles and joints associated with:

  • arthritis
  • simple backache
  • strains
  • sprains
  • bruises

Dosage and Administration

Adults and children over 18 years:

  • Apply to affected area. Massage into the painful area until thoroughly absorbed. Repeat as necessary but no more than 3 to 4

times daily.

  • Wash hands with soap and water after applying.

Children 18 years and younger:

  • Consult a doctor.

Description

Capsaicin .025%

Section 44425-7
  • Store in a cool, dry place.
  • Keep away from excessive heat or flame.
  • Tamper-evident for your protection. Use only if safety seal is intact

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 with a few days
  • redness is present
  • irritation develops.

Section 50567-7

When using this product:

  • avoid contact with eyes
  • do not apply to wounds or damaged skin
  • do not bandage tightly

Section 51727-6

Water, Magnesium Chloride, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Cetearyl Alcohol, Butyrospermum Parkii (Shea) Butter, Dimethyl Sulfone (MSM), Sodium Lactate, Glyceryl Stearate Citrate, Cetyl Palmitate, Glycerin, Glyceryl Stearate, Polyglyceryl-3 Diisostearate, Pentylene Glycol, Undecane, Xanthan Gum, Magnesium Sulfate, Tridecane, Potassium Chloride, Sodium Chloride, Calcium Chloride, Tocopheryl Acetate (Vitamin E), Hydroxyacetophenone, Panthenol, Allantoin, Pentaerythrityl Tetra-Di-T-Butyl Hydroxyhydrocinnamate, Sodium Hydroxide, Cymbopogon Flexuosus (East-Indian Lemongrass) Oil* *Organic

Section 51945-4

Section 53413-1

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

Report any serious side effects to number above.

Section 53414-9

If pregnant or breastfeeding,ask a health professional before use.

Section 55105-1

Topical Analgesic

Section 55106-9

Capsaicin .025%


Structured Label Content

Indications and Usage (34067-9)

Temporarily relieves minor aches and pains of muscles and joints associated with:

  • arthritis
  • simple backache
  • strains
  • sprains
  • bruises

Dosage and Administration (34068-7)

Adults and children over 18 years:

  • Apply to affected area. Massage into the painful area until thoroughly absorbed. Repeat as necessary but no more than 3 to 4

times daily.

  • Wash hands with soap and water after applying.

Children 18 years and younger:

  • Consult a doctor.

Warnings and Precautions (34071-1)

Use only as directed.

For external use only.

Section 44425-7 (44425-7)
  • Store in a cool, dry place.
  • Keep away from excessive heat or flame.
  • Tamper-evident for your protection. Use only if safety seal is intact

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 with a few days
  • redness is present
  • irritation develops.

Section 50567-7 (50567-7)

When using this product:

  • avoid contact with eyes
  • do not apply to wounds or damaged skin
  • do not bandage tightly

Section 51727-6 (51727-6)

Water, Magnesium Chloride, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Cetearyl Alcohol, Butyrospermum Parkii (Shea) Butter, Dimethyl Sulfone (MSM), Sodium Lactate, Glyceryl Stearate Citrate, Cetyl Palmitate, Glycerin, Glyceryl Stearate, Polyglyceryl-3 Diisostearate, Pentylene Glycol, Undecane, Xanthan Gum, Magnesium Sulfate, Tridecane, Potassium Chloride, Sodium Chloride, Calcium Chloride, Tocopheryl Acetate (Vitamin E), Hydroxyacetophenone, Panthenol, Allantoin, Pentaerythrityl Tetra-Di-T-Butyl Hydroxyhydrocinnamate, Sodium Hydroxide, Cymbopogon Flexuosus (East-Indian Lemongrass) Oil* *Organic

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

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

Report any serious side effects to number above.

Section 53414-9 (53414-9)

If pregnant or breastfeeding,ask a health professional before use.

Section 55105-1 (55105-1)

Topical Analgesic

Section 55106-9 (55106-9)

Capsaicin .025%


Advanced Ingredient Data


Raw Label Data

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