spray pain away (asutra)

spray pain away (asutra)
SPL v4
SPL
SPL Set ID c603e999-2316-496a-e053-2995a90ab4ed
Route
topical
Published
Effective Date 2021-06-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
capsaicin (0.025 g)
Inactive Ingredients
water magnesium chloride polysorbate 20 medium-chain triglycerides

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2021-06-30

Purpose

Capsaicin .025%.............Topical Analgesic

Description

Capsaicin .025%


Medication Information

Warnings

Use only as directed. For external use only.

Uses

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

  • arthritis
  • simple backache
  • strains
  • sprains
  • bruises
Purpose

Capsaicin .025%.............Topical Analgesic

Directions

Adults 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.
Other Information
  • 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.
Inactive Ingredients

Water, Magnesium Chloride, Polysorbate 20, Caprylic/Capric Triglyceride

Description

Capsaicin .025%

Section 50565-1

Keep out of reach of children.If accidentally ingested, get medical help or contact a 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
  • 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 51945-4

NDC:

72683-006-01

Asutra*

Spray

pain

away

Capsaicin .025%

Pain Relieving Spray

Refreshing Magnesium Oil

4 fl. oz. | 118 ml.

Paraben Free

Animal Test-Free PETA Vegan

Section 53414-9

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

Active Ingredients

Capsaicin .025%

Questions Or Comments?

888-819-6472; Monday-Friday, 9am-5pm CT; Report any serious side effects to number above.


Structured Label Content

Warnings

Use only as directed. For external use only.

Uses

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

  • arthritis
  • simple backache
  • strains
  • sprains
  • bruises
Purpose

Capsaicin .025%.............Topical Analgesic

Directions

Adults 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.
Other Information (Other information)
  • 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.
Inactive Ingredients (Inactive ingredients)

Water, Magnesium Chloride, Polysorbate 20, Caprylic/Capric Triglyceride

Section 50565-1 (50565-1)

Keep out of reach of children.If accidentally ingested, get medical help or contact a 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
  • 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 51945-4 (51945-4)

NDC:

72683-006-01

Asutra*

Spray

pain

away

Capsaicin .025%

Pain Relieving Spray

Refreshing Magnesium Oil

4 fl. oz. | 118 ml.

Paraben Free

Animal Test-Free PETA Vegan

Section 53414-9 (53414-9)

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

Active Ingredients (Active ingredients)

Capsaicin .025%

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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