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NDC 72342-0190-85 Pain Relief Roll-On 1.5 g/100g Details

Pain Relief Roll-On 1.5 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 CAMPHOR (NATURAL).

Product Information

NDC	72342-0190
Product ID	72342-190_3249d53d-2143-4461-9b9d-88943c53d032
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	Muscle
Non-Proprietary Name	Camphor (Natural)
Product Type	HUMAN OTC DRUG
Dosage Form	GEL
Route	TOPICAL
Active Ingredient Strength	1.5
Active Ingredient Units	g/100g
Substance Name	CAMPHOR (NATURAL)
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 72342-0190-85 (72342019085)

Pricing Information	N/A
NDC Package Code	72342-190-85
Billing NDC	72342019085
Package	85 g in 1 BOTTLE, WITH APPLICATOR (72342-190-85)
Marketing Start Date	2020-12-15
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL d94ae654-ce25-4bff-b9bd-24a0e0e8568a Details

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

Camphor 1.5%

Purpose

Topical Analgesic

Uses

For the temporary relief of pain

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 camphor

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

Arnica montana flower extract, cholecalciferol, denatured alcohol, ethylhexylglycerin, glycerin, hydroxyethylcellulose, magnesium chloride hexahydrate, Mentha piperita (peppermint) oil, phenoxyethanol, polysorbate 20, water

Questions or Comments?

J.R. WATKINS, LLC

OAKLAND, CA 94612

1-888-384-1945

JRWATKINS.COM

PRINCIPAL DISPLAY PANEL - 85 g Bottle Label

ESTD 1868

J.R.

WATKINS

REMEDIES FOR BODY™

MUSCLE

PAIN RELIEF

ROLL-ON

USED BY

ATHLETES

WITH NATURAL MAGNESIUM,

VITAMIN D, CAMPHOR

& PEPPERMINT

PENETRATING

PAIN RELIEF FOR

MUSCLE STRAINS

AND SORENESS,

AND ACHING JOINTS

Net wt. 3.0 oz (85 g)

PRINCIPAL DISPLAY PANEL - 85 g Bottle Label

INGREDIENTS AND APPEARANCE

PAIN RELIEF ROLL-ON MUSCLE

camphor (natural) gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:72342-190
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Camphor (Natural) (UNII: N20HL7Q941) (Camphor (Natural) - UNII:N20HL7Q941)	Camphor (Natural)	1.5 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
Arnica Montana Flower (UNII: OZ0E5Y15PZ)
Cholecalciferol (UNII: 1C6V77QF41)
Alcohol (UNII: 3K9958V90M)
Ethylhexylglycerin (UNII: 147D247K3P)
Glycerin (UNII: PDC6A3C0OX)
Hydroxyethyl Cellulose, Unspecified (UNII: T4V6TWG28D)
Magnesium Chloride (UNII: 02F3473H9O)
Peppermint Oil (UNII: AV092KU4JH)
Phenoxyethanol (UNII: HIE492ZZ3T)
Polysorbate 20 (UNII: 7T1F30V5YH)
Water (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:72342-190-85	85 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: 3249d53d-2143-4461-9b9d-88943c53d032

Set id: d94ae654-ce25-4bff-b9bd-24a0e0e8568a

Version: 1

Effective Time: 20201204