PAIN RELIEF EXTRA STRENGTH, COOLING- menthol, unspecified form aerosol, spray

Pain Relief by

Drug Labeling and Warnings

Pain Relief by is a Otc medication manufactured, distributed, or labeled by J.R. Watkins, LLC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

Menthol 6%

Purpose

Topical Analgesic

Uses

For the temporary relief of minor aches and pains of muscles and joints associated with

• simple backache
• arthritis
• strains
• bruises
• sprains

Warnings

For external use only.

Flammable:Keep away from fire or flame and heated surfaces.

Do not use

• On open wounds, damaged or irritated skin
• With a heading pad or TENS device
• With any other creams, ointments, sprays, liniments, or other topical products containing menthol

When using this product

• Do not bandage tightly
• Use only as directed
• Avoid contact with eyes or mucous membranes
• Contents under pressure
• Do not puncture or incinerate
• Do not store at temperature above 120 deg. F

Stop use and ask a doctor if

• Condition worsens
• you have sensitive skin
• Rash, itching, redness, or excessive irritation of skin develops
• Symptoms persist for more than 7 days
• Symptoms 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

• Adults and children 12 years of age and older:
• Apply to affected area not more 4 times a day
• Massage painful area until absorbed into skin
• Wash hands after each use with cold water
• Children under 12 years of age: consult a doctor.

Other information

• Store away from children
• Store in dry, well-ventilated conditions at room temperature (59-77°F)

Inactive ingredients

Aloe barbadensis leaf extract, Arnica montana flower extract, denatured alcohol, glycerin, Melaleuca alternafolia (tea tree) leaf oil, organic Ilex paraguariensis (yerba mate) leaf, tocopheryl acetate (vitamin E), water

Questions or Comments?

J.R WATKINS, LLC
OAKLAND, CA 94612
1-888-384-1945
JRWATKINS.COM

PRINCIPAL DISPLAY PANEL - 118 mL Bottle Label

EXTRA STRENGTH*

ESTD
1868
J.R.
WATKINS
REMEDIES FOR BODY™

COOLING

PAIN RELIEF SPRAY

WITH NATURAL MENTHOL,
ARNICA & VITAMIN E

FAST-ACTING MENTHOL
PAIN RELIEF FOR
BACKACHES, SORE MUSCLES,
& JOINT PAIN

4.0 fl oz (118 mL)

USED BY
ATHLETES

INGREDIENTS AND APPEARANCE

PAIN RELIEF  EXTRA STRENGTH, COOLING
menthol, unspecified form aerosol, spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72342-130
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A)	MENTHOL, UNSPECIFIED FORM	6 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
ALCOHOL (UNII: 3K9958V90M)
GLYCERIN (UNII: PDC6A3C0OX)
TEA TREE OIL (UNII: VIF565UC2G)
ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72342-130-18	118 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	12/15/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	12/15/2020

Labeler - J.R. Watkins, LLC. (081071049)