PAIN RELIEF EXTRA STRENGTH, COOLING- menthol, unspecified form gel

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

Stop use and ask a doctor if

• Condition worsens
• 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, carbomer homopolymer type C (allyl pentaerythritol crosslinked), denatured alcohol, ethylhexylglycerin, glycerin, Melaleuca alternafolia (tea tree) leaf oil, organic Ilex paraguariensis (yerba mate) leaf, phenoxyethanol, propylene glycol, triethanolamine, tocopheryl acetate (vitamin E), water

Questions or Comments?

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

PRINCIPAL DISPLAY PANEL - 113 g Tube Label

EXTRA STRENGTH*

ESTD 1868
J.R.
WATKINS
REMEDIES FOR BODY™

COOLING

PAIN RELIEF
GEL

WITH NATURAL MENTHOL,
ARNICA & VITAMIN E

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

USED BY
ATHLETES

NO-MESS APPLICATOR

Net wt. 4.0 oz (113 g)

INGREDIENTS AND APPEARANCE

PAIN RELIEF  EXTRA STRENGTH, COOLING
menthol, unspecified form gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72342-110
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 g

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)
ALCOHOL (UNII: 3K9958V90M)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
GLYCERIN (UNII: PDC6A3C0OX)
TEA TREE OIL (UNII: VIF565UC2G)
ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
TROLAMINE (UNII: 9O3K93S3TK)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72342-110-13	113 g in 1 TUBE, WITH APPLICATOR; 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)