Search by Drug Name or NDC

NDC 72342-0180-18 Pain Relief 1.5 g/100mL Details

Pain Relief 1.5 g/100mL

Pain Relief is a TOPICAL AEROSOL, SPRAY 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	72342-0180
Product ID	72342-180_c95bdcc4-19ef-4756-af64-30d6d3ded4b5
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	AEROSOL, SPRAY
Route	TOPICAL
Active Ingredient Strength	1.5
Active Ingredient Units	g/100mL
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 72342-0180-18 (72342018018)

Pricing Information	N/A
NDC Package Code	72342-180-18
Billing NDC	72342018018
Package	118 mL in 1 BOTTLE, SPRAY (72342-180-18)
Marketing Start Date	2020-12-15
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL f8bff018-fb4f-47b4-b8f8-4a496aede346 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 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
Contents under pressure
Do not puncture or incinerate
Do not store at temperature above 120 deg. F

Stop use and ask a doctor if

Condition worsens
you have sensitive skin
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
- Spray onto affected area and let absorb 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

Arnica montana flower extract, cholecalciferol, denatured alcohol, ethylhexylglycerin, glycerin, 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 - 118 mL Bottle Label

ESTD 1868

J.R.

WATKINS

REMEDIES FOR BODY™

MUSCLE

PAIN RELIEF SPRAY

WITH NATURAL MAGNESIUM,

VITAMIN D, CAMPHOR & PEPPERMINT

PENETRATING PAIN RELIEF

FOR MUSCLE STRAINS AND

SORENESS, AND

ACHING JOINTS

USED BY

ATHLETES

4.0 fl oz (118 mL)

PRINCIPAL DISPLAY PANEL - 118 mL Bottle Label

INGREDIENTS AND APPEARANCE

PAIN RELIEF MUSCLE

camphor (natural) aerosol, spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:72342-180
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 mL

Ingredient Name	Strength
Inactive Ingredients
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
Cholecalciferol (UNII: 1C6V77QF41)
ALCOHOL (UNII: 3K9958V90M)
Ethylhexylglycerin (UNII: 147D247K3P)
Glycerin (UNII: PDC6A3C0OX)
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:72342-180-18	118 mL in 1 BOTTLE, SPRAY; 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: c95bdcc4-19ef-4756-af64-30d6d3ded4b5

Set id: f8bff018-fb4f-47b4-b8f8-4a496aede346

Version: 1

Effective Time: 20201207