PAIN RELIEF- menthol spray

Pain Relief by

Drug Labeling and Warnings

Pain Relief by is a Otc medication manufactured, distributed, or labeled by Sagely Enterprises Inc., PakLab. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Menthol 10%

Purpose

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

Uses

temporarily relieves the minor aches and pains of muscles and joints associated with:

• strains
• bruises
• simple backache
• arthritis
• sprains

Warnings

For external use only.

Do not use

• on wounds or damaged, broken, or irritated skin
• with a heating pad

When using this product

• avoid contact with eyes or mucous membranes
• do not bandage tightly

Stop use and ask a doctor if

• condition worsens or symptoms persist for more than 7 days or clear up and occur again within a few days

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

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• Use only as directed
• Adults and children 12 years of age and older: apply to affected area not more than 3 to 4 times daily
• Children under 12 years of age: ask a doctor

Inactive ingredients

SD Alcohol 40-B, Water, Sambucus Nigra Fruit Extract, Boswellia Serrata Extract, Camphor, Mentha Piperita Oil, Glycerin, Arnica Montana Flower Extract

PRINCIPAL DISPLAY PANEL

Sagely Naturals

Extra Strength

Pain Relief Spray

95% Natural Ingredients

Instant Cooling

with 10% Menthol

2 Fl Oz / 60 mL

INGREDIENTS AND APPEARANCE

PAIN RELIEF 
menthol spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82075-430
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	10 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
ALCOHOL (UNII: 3K9958V90M)
WATER (UNII: 059QF0KO0R)
INDIAN FRANKINCENSE (UNII: 4PW41QCO2M)
EUROPEAN ELDERBERRY (UNII: BQY1UBX046)
MENTHA PIPERITA (UNII: 79M2M2UDA9)
CAMPHOR (NATURAL) (UNII: N20HL7Q941)
GLYCERIN (UNII: PDC6A3C0OX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82075-430-30	1 in 1 CARTON	11/19/2021
1		60 g in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	11/19/2021

Labeler - Sagely Enterprises Inc. (117049032)

Establishment
Name	Address	ID/FEI	Business Operations
PakLab		078717086	manufacture(82075-430)