Pain-A-Trate Extra Strength Pain-Relieving Cream

Manufacturer: Melaleuca, Inc. | Melaleuca, Inc
Effective date: 2020-03-19
Label type: HUMAN OTC DRUG LABEL
Version: 5
Source: full-release
Hydrated at: 2026-05-31 23:04:04

Label at a glance#

ProductPain-A-Trate Extra Strength Pain-Relieving

Active ingredientCAMPHOR (SYNTHETIC), MENTHOL, METHYL SALICYLATE

Label structure14 sections

Storage and handling

Other information do not store above 95°F (35°C)

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredients
Camphor 3.25%
Menthol, 1.5%
Methyl Salicylate, 15%

OTC - PURPOSE SECTION

Purpose
Topical analgesic

INDICATIONS & USAGE SECTION

Uses for the temporary relief of minor aches and pains of muscles and joints. Provides penetrating pain relief of aches and pains associated with:

simple backache
arthritis
strains
bruises
sprains

WARNINGS SECTION

Warnings
For external use only

OTC - DO NOT USE SECTION

Do not use

on wounds or damaged skin
with a heating pad
on a child under 12 years of age with arthritis-like conditions

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have redness over the affected area.

OTC - WHEN USING SECTION

When using this product

avoid contact with eyes or mucus membranes
do not bandage tightly

OTC - STOP USE SECTION

Stop use and ask a doctor if

condition worsens or symptoms persist for more than 7 days
excessive skin irritation occurs

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children to avoid accidental ingestion. If swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

Directions

apply generously to affected area with gentle massage
do not apply more than 3 to 4 times daily

STORAGE AND HANDLING SECTION

Other information do not store above 95°F (35°C)

INACTIVE INGREDIENT SECTION

Inactive ingredients acrylates/C10-30 alkyl acrylate crosspolymer, benzyl alcohol, cetyl alcohol, deionized water, FD and C blue no. 1, FD and C yellow no. 5, glyceryl monostearate SE, Melaleuca Oil (T36-C5 ^® brand), polysorbate 20, sorbitan stearate, steric acid, triethanolamine

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1091381	camphor 3.25 % / menthol 1.5 % / methyl salicylate 15 % Topical Cream	PSN	5
1091381	camphor 32.5 MG/ML / menthol 15 MG/ML / methyl salicylate 150 MG/ML Topical Cream	SCD	5
1091381	camphor 3.25 % / menthol 1.5 % / methyl salicylate 15 % Topical Cream	SY	5

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
54473-150-01	2022-01-28	C162847	48780-1	9d75b9d0-edb5-f424-e053-dadaa90a57ce	Pain-A-Trate Extra Strength Pain-Relieving Cream
54473-150-03	2022-01-28	C162847	48780-1	9d75b9d0-edb5-f424-e053-dadaa90a57ce	Pain-A-Trate Extra Strength Pain-Relieving Cream
54473-150-01	2020-03-19	C162847	48780-1	9d75b9d0-edb5-f424-e053-dadaa90a57ce	Pain-A-Trate Extra Strength Pain-Relieving Cream
54473-150-03	2020-03-19	C162847	48780-1	9d75b9d0-edb5-f424-e053-dadaa90a57ce	Pain-A-Trate Extra Strength Pain-Relieving Cream
54473-150-01	2020-01-31	C162847	48780-1	9d75b9d0-edb5-f424-e053-dadaa90a57ce	Pain-A-Trate Extra Strength Pain-Relieving Cream
54473-150-03	2020-01-31	C162847	48780-1	9d75b9d0-edb5-f424-e053-dadaa90a57ce	Pain-A-Trate Extra Strength Pain-Relieving Cream

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
54473-150-01	Pain-A-TrateExtra Strength Pain-Relieving	28 g in 1 TUBE	CREAM	28		5
54473-150-03	Pain-A-TrateExtra Strength Pain-Relieving	85 g in 1 TUBE	CREAM	85		5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
54473-150	PAIN-A-TRATE EXTRA STRENGTH PAIN-RELIEVING (CAMPHOR AND MENTHOL AND METHYL SALICYLATE) CREAM [MELALEUCA, INC.]	5	Legacy NDC, 2 package rows	20200320_cb23ed39-eba2-412b-8737-0218b87d1669.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
CAMPHOR (SYNTHETIC)	ACTIVE INGREDIENT	5TJD82A1ET	3
MENTHOL	ACTIVE INGREDIENT	L7T10EIP3A	3
METHYL SALICYLATE	ACTIVE INGREDIENT	LAV5U5022Y	3
CAMPHOR (SYNTHETIC)	ACTIVE MOIETY	5TJD82A1ET	3
MENTHOL	ACTIVE MOIETY	L7T10EIP3A	3
SALICYLIC ACID	ACTIVE MOIETY	O414PZ4LPZ	3
Benzyl Alcohol	INACTIVE INGREDIENT	LKG8494WBH	3
Carbomer Copolymer Type B	INACTIVE INGREDIENT	1G56KV7BUJ	3
Cetyl Alcohol	INACTIVE INGREDIENT	936JST6JCN	3
FD&C Blue No. 1	INACTIVE INGREDIENT	H3R47K3TBD	3
FD&C Yellow No. 5	INACTIVE INGREDIENT	I753WB2F1M	3
Glyceryl monostearate	INACTIVE INGREDIENT	230OU9XXE4	3
Polysorbate 20	INACTIVE INGREDIENT	7T1F30V5YH	3
Sorbitan monostearate	INACTIVE INGREDIENT	NVZ4I0H58X	3
Stearic Acid	INACTIVE INGREDIENT	4ELV7Z65AP	3
Tea Tree Oil	INACTIVE INGREDIENT	VIF565UC2G	3
Trolamine	INACTIVE INGREDIENT	9O3K93S3TK	3
Water	INACTIVE INGREDIENT	059QF0KO0R	3

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 18 matching rows.

Pain-A-Trate Extra Strength Pain-Relieving
Camphor and Menthol and Methyl Salicylate
WATER
GLYCERYL MONOSTEARATE
STEARIC ACID
CETYL ALCOHOL
SORBITAN MONOSTEARATE
POLYSORBATE 20
TEA TREE OIL
TROLAMINE
CARBOMER COPOLYMER TYPE B
BENZYL ALCOHOL
FD&C BLUE NO. 1
FD&C YELLOW NO. 5
CAMPHOR (SYNTHETIC)
MENTHOL
METHYL SALICYLATE
SALICYLIC ACID

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
54473-150	54473-150-03, 54473-150-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
WATER	059QF0KO0R	IACT
GLYCERYL MONOSTEARATE	230OU9XXE4	IACT
STEARIC ACID	4ELV7Z65AP	IACT
CETYL ALCOHOL	936JST6JCN	IACT
SORBITAN MONOSTEARATE	NVZ4I0H58X	IACT
POLYSORBATE 20	7T1F30V5YH	IACT
TEA TREE OIL	VIF565UC2G	IACT
TROLAMINE	9O3K93S3TK	IACT
CARBOMER COPOLYMER TYPE B	1G56KV7BUJ	IACT
BENZYL ALCOHOL	LKG8494WBH	IACT
FD&C BLUE NO. 1	H3R47K3TBD	IACT
FD&C YELLOW NO. 5	I753WB2F1M	IACT
CAMPHOR (SYNTHETIC)	5TJD82A1ET	ACTIB
MENTHOL	L7T10EIP3A	ACTIB
METHYL SALICYLATE	LAV5U5022Y	ACTIB

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 4 · 237 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
FD&C Blue No. 1	FD&C BLUE NO. 1	H3R47K3TBD	TABLET, DELAYED RELEASE / ORAL	0.01 mg		Exact identifier — unii candidate 37 equally ranked IID candidates
Cetyl Alcohol	CETYL ALCOHOL	936JST6JCN	TABLET, FILM COATED, EXTENDED RELEASE / ORAL	59 mg		Exact identifier — unii candidate 20 equally ranked IID candidates
Benzyl Alcohol	BENZYL ALCOHOL	LKG8494WBH	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRACAVERNOUS		18 mg	Exact identifier — unii candidate 50 equally ranked IID candidates
FD&C Yellow No. 5	FD&C YELLOW NO. 5	I753WB2F1M	TABLET, FILM COATED / ORAL	1.68 mg		Exact identifier — unii candidate 22 equally ranked IID candidates
Trolamine	TROLAMINE	9O3K93S3TK	SOLUTION / TOPICAL	NA		Exact identifier — unii candidate 22 equally ranked IID candidates
Sorbitan monostearate	SORBITAN MONOSTEARATE	NVZ4I0H58X	SUSPENSION / ORAL	62.5 mg/5ml		Exact identifier — unii candidate 11 equally ranked IID candidates
Polysorbate 20	POLYSORBATE 20	7T1F30V5YH	TABLET / ORAL		17 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
Cetyl Alcohol	CETYL ALCOHOL	936JST6JCN	TABLET, COATED / ORAL	0.25 mg		Exact identifier — unii candidate 20 equally ranked IID candidates
Trolamine	TROLAMINE	9O3K93S3TK	DROPS / NASAL	NA		Exact identifier — unii candidate 22 equally ranked IID candidates
Benzyl Alcohol	BENZYL ALCOHOL	LKG8494WBH	TABLET / ORAL	1.06 mg		Exact identifier — unii candidate 50 equally ranked IID candidates
Glyceryl monostearate	GLYCERYL MONOSTEARATE	230OU9XXE4	CREAM / TOPICAL		836 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
FD&C Blue No. 1	FD&C BLUE NO. 1	H3R47K3TBD	SOLUTION / DENTAL	NA		Exact identifier — unii candidate 37 equally ranked IID candidates
Cetyl Alcohol	CETYL ALCOHOL	936JST6JCN	TABLET, ORALLY DISINTEGRATING / ORAL		9 mg	Exact identifier — unii candidate 20 equally ranked IID candidates
Benzyl Alcohol	BENZYL ALCOHOL	LKG8494WBH	SUSPENSION / AURICULAR (OTIC)	0.9 %w/v		Exact identifier — unii candidate 50 equally ranked IID candidates
FD&C Blue No. 1	FD&C BLUE NO. 1	H3R47K3TBD	DOUCHE / VAGINAL	NA		Exact identifier — unii candidate 37 equally ranked IID candidates
Benzyl Alcohol	BENZYL ALCOHOL	LKG8494WBH	CAPSULE / ORAL		450 mg	Exact identifier — unii candidate 50 equally ranked IID candidates
FD&C Blue No. 1	FD&C BLUE NO. 1	H3R47K3TBD	CAPSULE, COATED PELLETS / ORAL	NA		Exact identifier — unii candidate 37 equally ranked IID candidates
Benzyl Alcohol	BENZYL ALCOHOL	LKG8494WBH	INJECTION, SUSPENSION / SOFT TISSUE		40 mg	Exact identifier — unii candidate 50 equally ranked IID candidates
Polysorbate 20	POLYSORBATE 20	7T1F30V5YH	TABLET, EXTENDED RELEASE / ORAL	4.2 mg		Exact identifier — unii candidate 28 equally ranked IID candidates
Cetyl Alcohol	CETYL ALCOHOL	936JST6JCN	AEROSOL / TOPICAL	1.16 %w/w		Exact identifier — unii candidate 20 equally ranked IID candidates
Glyceryl monostearate	GLYCERYL MONOSTEARATE	230OU9XXE4	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL		23 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
Benzyl Alcohol	BENZYL ALCOHOL	LKG8494WBH	SOLUTION / INTRAMUSCULAR		54 mg	Exact identifier — unii candidate 50 equally ranked IID candidates
FD&C Blue No. 1	FD&C BLUE NO. 1	H3R47K3TBD	SOAP / TOPICAL	0.01 %w/w		Exact identifier — unii candidate 37 equally ranked IID candidates
Glyceryl monostearate	GLYCERYL MONOSTEARATE	230OU9XXE4	CAPSULE, DELAYED RELEASE / ORAL		15 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
Polysorbate 20	POLYSORBATE 20	7T1F30V5YH	SUSPENSION / AURICULAR (OTIC)	0.1 %w/v		Exact identifier — unii candidate 28 equally ranked IID candidates
Benzyl Alcohol	BENZYL ALCOHOL	LKG8494WBH	SOLUTION / TOPICAL	2 %w/w		Exact identifier — unii candidate 50 equally ranked IID candidates
Polysorbate 20	POLYSORBATE 20	7T1F30V5YH	CREAM / TOPICAL		108 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
Trolamine	TROLAMINE	9O3K93S3TK	CREAM / TOPICAL	1 %w/w		Exact identifier — unii candidate 22 equally ranked IID candidates
Stearic Acid	STEARIC ACID	4ELV7Z65AP	TABLET, CHEWABLE / ORAL		180 mg	Exact identifier — unii candidate 26 equally ranked IID candidates
FD&C Blue No. 1	FD&C BLUE NO. 1	H3R47K3TBD	FILM, SOLUBLE / ORAL	0.04 mg		Exact identifier — unii candidate 37 equally ranked IID candidates
Trolamine	TROLAMINE	9O3K93S3TK	GEL, METERED / TRANSDERMAL		14 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
Trolamine	TROLAMINE	9O3K93S3TK	SPONGE / TOPICAL	11 %w/w		Exact identifier — unii candidate 22 equally ranked IID candidates
Benzyl Alcohol	BENZYL ALCOHOL	LKG8494WBH	LOTION / TOPICAL		4000 mg	Exact identifier — unii candidate 50 equally ranked IID candidates
Polysorbate 20	POLYSORBATE 20	7T1F30V5YH	TAMPON / VAGINAL	64.8 mg		Exact identifier — unii candidate 28 equally ranked IID candidates
FD&C Yellow No. 5	FD&C YELLOW NO. 5	I753WB2F1M	CONCENTRATE / BUCCAL	NA		Exact identifier — unii candidate 22 equally ranked IID candidates
Sorbitan monostearate	SORBITAN MONOSTEARATE	NVZ4I0H58X	SUPPOSITORY / VAGINAL	NA		Exact identifier — unii candidate 11 equally ranked IID candidates
Cetyl Alcohol	CETYL ALCOHOL	936JST6JCN	TABLET, FILM COATED / ORAL	NA		Exact identifier — unii candidate 20 equally ranked IID candidates
Trolamine	TROLAMINE	9O3K93S3TK	EMULSION / TOPICAL	0.5 %w/w		Exact identifier — unii candidate 22 equally ranked IID candidates
Polysorbate 20	POLYSORBATE 20	7T1F30V5YH	SUSPENSION / OPHTHALMIC	0.05 %w/v		Exact identifier — unii candidate 28 equally ranked IID candidates
Benzyl Alcohol	BENZYL ALCOHOL	LKG8494WBH	INJECTION / SUBCONJUNCTIVAL		252 mg	Exact identifier — unii candidate 50 equally ranked IID candidates
Glyceryl monostearate	GLYCERYL MONOSTEARATE	230OU9XXE4	TABLET / ORAL	33.34 mg		Exact identifier — unii candidate 21 equally ranked IID candidates
Benzyl Alcohol	BENZYL ALCOHOL	LKG8494WBH	SUSPENSION / ORAL		100 mg	Exact identifier — unii candidate 50 equally ranked IID candidates
FD&C Yellow No. 5	FD&C YELLOW NO. 5	I753WB2F1M	SUPPOSITORY / VAGINAL	NA		Exact identifier — unii candidate 22 equally ranked IID candidates
FD&C Blue No. 1	FD&C BLUE NO. 1	H3R47K3TBD	LIQUID / TOPICAL	NA		Exact identifier — unii candidate 37 equally ranked IID candidates
Polysorbate 20	POLYSORBATE 20	7T1F30V5YH	SOLUTION / TOPICAL	15 %w/w		Exact identifier — unii candidate 28 equally ranked IID candidates
Benzyl Alcohol	BENZYL ALCOHOL	LKG8494WBH	INJECTION, SUSPENSION / INTRALESIONAL		20 mg	Exact identifier — unii candidate 50 equally ranked IID candidates
Polysorbate 20	POLYSORBATE 20	7T1F30V5YH	AEROSOL, FOAM / TOPICAL	3.7 %w/w		Exact identifier — unii candidate 28 equally ranked IID candidates
Polysorbate 20	POLYSORBATE 20	7T1F30V5YH	INJECTION, SOLUTION / INTRAVENOUS		30 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
FD&C Blue No. 1	FD&C BLUE NO. 1	H3R47K3TBD	CAPSULE, LIQUID FILLED / ORAL	0.08 mg		Exact identifier — unii candidate 37 equally ranked IID candidates
FD&C Blue No. 1	FD&C BLUE NO. 1	H3R47K3TBD	CAPSULE / ORAL	26.3 mg		Exact identifier — unii candidate 37 equally ranked IID candidates
Benzyl Alcohol	BENZYL ALCOHOL	LKG8494WBH	INJECTION, SOLUTION / INTRA-ARTICULAR		23 mg	Exact identifier — unii candidate 50 equally ranked IID candidates
Cetyl Alcohol	CETYL ALCOHOL	936JST6JCN	SUSPENSION / AURICULAR (OTIC)	1 %w/v		Exact identifier — unii candidate 20 equally ranked IID candidates
Stearic Acid	STEARIC ACID	4ELV7Z65AP	TABLET / SUBLINGUAL	9 mg		Exact identifier — unii candidate 26 equally ranked IID candidates
FD&C Blue No. 1	FD&C BLUE NO. 1	H3R47K3TBD	MOUTHWASH / BUCCAL	NA		Exact identifier — unii candidate 37 equally ranked IID candidates
Benzyl Alcohol	BENZYL ALCOHOL	LKG8494WBH	SPRAY, METERED / NASAL	5 mg/1ml		Exact identifier — unii candidate 50 equally ranked IID candidates
Glyceryl monostearate	GLYCERYL MONOSTEARATE	230OU9XXE4	TABLET, EXTENDED RELEASE / ORAL		529 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
Polysorbate 20	POLYSORBATE 20	7T1F30V5YH	SHAMPOO / TOPICAL	8 %w/w		Exact identifier — unii candidate 28 equally ranked IID candidates
Polysorbate 20	POLYSORBATE 20	7T1F30V5YH	AEROSOL, FOAM / VAGINAL	3 %w/w		Exact identifier — unii candidate 28 equally ranked IID candidates
Benzyl Alcohol	BENZYL ALCOHOL	LKG8494WBH	INJECTION / SOFT TISSUE		23 mg	Exact identifier — unii candidate 50 equally ranked IID candidates
Glyceryl monostearate	GLYCERYL MONOSTEARATE	230OU9XXE4	SUSPENSION / AURICULAR (OTIC)	0.5 %w/v		Exact identifier — unii candidate 21 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
a13d2b4d-ea05-3209-e053-2995a90ae140			cb23ed39-eba2-412b-8737-0218b87d1669	2020-03-19	Warnings	Exact identifier spl id: a13d2b4d-ea05-3209-e053-2995a90ae140 spl set id: cb23ed39-eba2-412b-8737-0218b87d1669

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.