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NDC 72342-0200-16 Pain Relief 1.5 g/100g Details

Pain Relief 1.5 g/100g

Pain Relief is a TOPICAL LOTION 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	72342-0200
Product ID	72342-200_a18a1eeb-e9f3-4918-9416-ef642547fe80
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
Non-Proprietary Name	Camphor (Natural)
Product Type	HUMAN OTC DRUG
Dosage Form	LOTION
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 72342-0200-16 (72342020016)

Pricing Information	N/A
NDC Package Code	72342-200-16
Billing NDC	72342020016
Package	116 g in 1 TUBE, WITH APPLICATOR (72342-200-16)
Marketing Start Date	2020-12-15
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 1dc21c95-b419-4175-85f8-040b73060d37 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.

Do Not Use

On open wounds, damaged or irriated skin
With a heating 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 Poison Control Center right away.

Directions

Adults and children 12 years of age and over:

Apply to affected area not more than 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 (59-77F)

Inactive ingredients

Butyrospermum parkii (shea) butter, caprylic/capric triglyceride, cetearyl alcohol, cetearyl glucoside, cholecalciferol, coco-capyrlate/caprate, Cocos nucifera (coconut) oil, ethylhexylglycerin, glycerin, glyceryl stearate, jojoba esters, magnesium chloride hexahydrate, Mentha piperita (peppermint) oil, PEG-100 stearate, phenoxyethanol, sodium hydroxide, water, xanthan gum.

Questions or Comments?

J.R WATKINS, LLC

OAKLAND, CA 94612

1-888-384-1945

PRINCIPAL DISPLAY PANEL - 116 g Tube Label

ESTD

1868

J.R

WATKINS

REMEDIES FOR BODY™

MUSCLE

PAIN RELIEF

LOTION

WITH NATURAL MAGNESIUM,

VITAMIN D, CAMPHOR

& PEPPERMINT

PENETRATING

PAIN RELIEF FOR

MUSCLE STRAINS

AND SORENESS,

AND ACHING JOINTS

USED BY

ATHLETES

Net wt. 4.1 oz (116 g)

PRINCIPAL DISPLAY PANEL - 116 g Tube Label

INGREDIENTS AND APPEARANCE

PAIN RELIEF MUSCLE

camphor (natural) lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:72342-200
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
Shea Butter (UNII: K49155WL9Y)
Medium-Chain Triglycerides (UNII: C9H2L21V7U)
Cetostearyl Alcohol (UNII: 2DMT128M1S)
Cetearyl Glucoside (UNII: 09FUA47KNA)
Cholecalciferol (UNII: 1C6V77QF41)
COCOYL CAPRYLOCAPRATE (UNII: 8D9H4QU99H)
Coconut Oil (UNII: Q9L0O73W7L)
Ethylhexylglycerin (UNII: 147D247K3P)
Glycerin (UNII: PDC6A3C0OX)
Glyceryl Monostearate (UNII: 230OU9XXE4)
HYDROGENATED JOJOBA OIL, RANDOMIZED (UNII: Q47ST02F58)
Magnesium Chloride (UNII: 02F3473H9O)
Peppermint Oil (UNII: AV092KU4JH)
PEG-100 Stearate (UNII: YD01N1999R)
Phenoxyethanol (UNII: HIE492ZZ3T)
Sodium Hydroxide (UNII: 55X04QC32I)
Water (UNII: 059QF0KO0R)
Xanthan Gum (UNII: TTV12P4NEE)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:72342-200-16	116 g in 1 TUBE, 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: a18a1eeb-e9f3-4918-9416-ef642547fe80

Set id: 1dc21c95-b419-4175-85f8-040b73060d37

Version: 1

Effective Time: 20201207