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NDC 72342-0120-79 Pain Relief Roll On 6 g/100g Details

Pain Relief Roll On 6 g/100g

Pain Relief Roll On is a TOPICAL GEL in the HUMAN OTC DRUG category. It is labeled and distributed by J.R. Watkins, LLC.. The primary component is MENTHOL, UNSPECIFIED FORM.

Product Information

NDC	72342-0120
Product ID	72342-120_9664d70d-0ff1-45ad-9539-2ea07ae96c3f
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Pain Relief Roll On
Proprietary Name Suffix	Extra Strength, Cooling
Non-Proprietary Name	MENTHOL, UNSPECIFIED FORM
Product Type	HUMAN OTC DRUG
Dosage Form	GEL
Route	TOPICAL
Active Ingredient Strength	6
Active Ingredient Units	g/100g
Substance Name	MENTHOL, UNSPECIFIED FORM
Labeler Name	J.R. Watkins, LLC.
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part348
Listing Certified Through	2024-12-31

Package

Package Images

NDC 72342-0120-79 (72342012079)

Pricing Information	N/A
NDC Package Code	72342-120-79
Billing NDC	72342012079
Package	79 g in 1 BOTTLE, WITH APPLICATOR (72342-120-79)
Marketing Start Date	2020-12-15
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL a455e126-4c5e-489c-9178-0f0636d76736 Details

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 - 79 g Bottle Label

EXTRA STRENGTH*

ESTD 1868

J.R.

WATKINS

REMEDIES FOR BODY™

COOLING

PAIN RELIEF

ROLL-ON

USED BY

ATHLETES

WITH NATURAL MENTHOL,

ARNICA & VITAMIN E

FAST-ACTING

MENTHOL PAIN RELIEF

FOR BACKACHES,

SORE MUSCLES,

& JOINT PAIN

Net wt. 2.8 oz (79 g)

PRINCIPAL DISPLAY PANEL - 79 g Bottle Label

INGREDIENTS AND APPEARANCE

PAIN RELIEF ROLL ON EXTRA STRENGTH, COOLING

menthol, unspecified form gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:72342-120
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:72342-120-79	79 g in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product	12/15/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part348	12/15/2020

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

Revised: 12/2020

Document Id: 9664d70d-0ff1-45ad-9539-2ea07ae96c3f

Set id: a455e126-4c5e-489c-9178-0f0636d76736

Version: 1

Effective Time: 20201208