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NDC 72342-0210-05 Pain Relief 280 mg/1 Details

Pain Relief 280 mg/1

Pain Relief is a TOPICAL PATCH 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	72342-0210
Product ID	72342-210_80e891af-9856-4521-943c-74c0d2e10204
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
Proprietary Name Suffix	Muscle Relief
Non-Proprietary Name	Camphor (Natural)
Product Type	HUMAN OTC DRUG
Dosage Form	PATCH
Route	TOPICAL
Active Ingredient Strength	280
Active Ingredient Units	mg/1
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 72342-0210-05 (72342021005)

Pricing Information	N/A
NDC Package Code	72342-210-05
Billing NDC	72342021005
Package	5 POUCH in 1 BOX (72342-210-05) / 1 PATCH in 1 POUCH
Marketing Start Date	2021-03-15
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 356b812e-3165-4623-b31c-b278c65139bf Details

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

Camphor 3.1%

Purpose

Topical Analgesic

Uses

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

simple backache
arthritis
strains
bruises

Warnings

For external use only.

Ask a doctor before use if you have

Sensitive Skin

When using this product

use only as directed
avoid contact with the eyes and mucous membranes
do not apply to wounds or damaged skin
do not bandage tightly or use a heating pad

Stop use and ask a doctor if

excessive redness or irritation is present
condition worsens
pain persist for more than 7 days
symptoms clear up and occur again within a few days

Do not use

with any other creams, ointments, sprays, liniments, or other topical products containing camphor.

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 and over:

gently fold patch in half and remove one side of backing. Apply exposed adhesive to the site of pain.
remove remaining film from the other side and finish applying to skin
use on affected areas for up to 12 hours. Children 12 years of younger: ask a doctor

Other information

store at room temperature, do not refrigerate or freeze

Inactive ingredients

cholecalciferol, dihydroxyaluminum aminoacetate, ethylhexylglycerin, glycerin, iodopropynyl butylcarbamate, kaolin, magnesium chloride hexahydrate, Mentha piperita oil, phenoxyethanol, polyacrylic acid, polysorbate 80, povidone, propylene glycol, sodium polyacrylate, tartaric acid, titanium dioxide, water

Questions or Comments?

J.R WATKINS, LLC

OAKLAND, CA 94612

1-888-384-1945

PRINCIPAL DISPLAY PANEL - 5 Patch Box

ESTD 1868

J.R.

WATKINS

REMEDIES FOR BODY™

MUSCLE

PAIN RELIEF PATCHES

WITH MAGNESIUM, CAMPHOR & VITAMIN D

Camphor, Vitamin D

& Peppermint

Crafted for muscle

pain relief

Mess-free

application

PENETRATING PAIN RELIEF FOR

MUSCLE STRAINS AND SORENESS,

AND ACHING JOINTS

USED BY

ATHLETES

5 INDIVIDUALLY PACKAGED PATCHES

5.5"x3.94" (14 cm x 10 cm)

INGREDIENTS AND APPEARANCE

PAIN RELIEF MUSCLE RELIEF

camphor (natural) patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:72342-210
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Camphor (Natural) (UNII: N20HL7Q941) (Camphor (Natural) - UNII:N20HL7Q941)	Camphor (Natural)	280 mg

Ingredient Name	Strength
Inactive Ingredients
Cholecalciferol (UNII: 1C6V77QF41)
Dihydroxyaluminum Aminoacetate (UNII: DO250MG0W6)
Ethylhexylglycerin (UNII: 147D247K3P)
Glycerin (UNII: PDC6A3C0OX)
Iodopropynyl Butylcarbamate (UNII: 603P14DHEB)
Kaolin (UNII: 24H4NWX5CO)
Magnesium Chloride (UNII: 02F3473H9O)
Peppermint Oil (UNII: AV092KU4JH)
Phenoxyethanol (UNII: HIE492ZZ3T)
Polyacrylic Acid (8000 MW) (UNII: 73861X4K5F)
Polysorbate 80 (UNII: 6OZP39ZG8H)
Povidone, Unspecified (UNII: FZ989GH94E)
Propylene Glycol (UNII: 6DC9Q167V3)
Sodium Polyacrylate (8000 MW) (UNII: 285CYO341L)
Tartaric Acid (UNII: W4888I119H)
Titanium Dioxide (UNII: 15FIX9V2JP)
Water (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:72342-210-05	5 in 1 BOX	03/15/2021
1		1 in 1 POUCH; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	03/15/2021

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

Revised: 3/2021

Document Id: 80e891af-9856-4521-943c-74c0d2e10204

Set id: 356b812e-3165-4623-b31c-b278c65139bf

Version: 1

Effective Time: 20210309