SPRAYPAIN AWAY- capsaicin spray

SprayPain Away by

Drug Labeling and Warnings

SprayPain Away by is a Otc medication manufactured, distributed, or labeled by SOLITEINT Kozmetikum gyarto es forgalmazo, termelo es kereskedelmi Korlatolt Felelossegu Tarsasag. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Capsaicin .025%

Purpose

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

Uses

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

• arthritis
• simple backache
• strains
• sprains
• bruises

Warnings

Use only as directed. For external use only.

When using this product:

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

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.

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

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

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

Questions or Comments?

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

PRINCIPAL DISPLAY PANEL

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

INGREDIENTS AND APPEARANCE

SPRAYPAIN AWAY 
capsaicin spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75249-006
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM)	CAPSAICIN	0.025 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75249-006-01	118 g in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	06/30/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	06/30/2021

Labeler - SOLITEINT Kozmetikum gyarto es forgalmazo, termelo es kereskedelmi Korlatolt Felelossegu Tarsasag (401476254)

Establishment
Name	Address	ID/FEI	Business Operations
SOLITEINT Kozmetikum gyarto es forgalmazo, termelo es kereskedelmi Korlatolt Felelossegu Tarsasag		401476254	manufacture(75249-006)