SPRAYPAIN AWAY- capsaicin spray

SprayPain Away by

Drug Labeling and Warnings

SprayPain Away by is a Otc medication manufactured, distributed, or labeled by Proximity Capital Partners LLC dba Asutra, 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: 72683-006
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: 72683-006-01	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 - Proximity Capital Partners LLC dba Asutra (081214985)

Establishment
Name	Address	ID/FEI	Business Operations
SOLITEINT Kozmetikum gyarto es forgalmazo, termelo es kereskedelmi Korlatolt Felelossegu Tarsasag		401476254	manufacture(72683-006)