Arthritis

Manufacturer: Cardinal Health
Effective date: 2012-10-04
Label type: HUMAN OTC DRUG LABEL
Version: 2
Source: legacy-cache
Hydrated at: 2026-08-02 01:44:41

Label at a glance#

ProductArthritis Leader

Active ingredientTrolamine Salicylate

Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Trolamine Salicylate 10.0%

INDICATIONS & USAGE SECTION

Uses

Temporarily relieves minor pain associated with: arthritis, simple backache, muscle strains, sprains, bruises, and cramps.

WARNINGS SECTION

Warnings

For external use only.

Allergy alert: if prone to allergic reaction from aspirin or salicylate, contact a doctor before use

When using this product: use only as directed, do not bandage tightly or use with a heating pad, avoid contact with eyes or mucous membranes, and do no apply to wounds or damaged skin

Stop use and ask doctor if: condition worsens, symptoms persist for more than 7 days or clear up and occur again within a few days, redness present, or irritation develops

If pregnant or breast-feeding, ask a health care professional before use

DOSAGE & ADMINISTRATION SECTION

Directions

Adults and children over 12 years of age: apply generously to affected area, massage into painful area until thoroughly absorbed into skin, repeat as necessary, but not more than 4 times daily. Children 12 years or younger: ask a doctor.

INACTIVE INGREDIENT SECTION

Inactive ingredients

Aloe Barbadensis Leaf Juice, Cetyl Alcohol, Glycerin, Methylparaben, Mineral Oil, Potassium Phosphate, Propylparaben, Stearic Acid, Triethanolamine, Water.

OTC - PURPOSE SECTION

Purpose

Pain relieving gel.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center immediately.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Leader Arthritis Cream with Aloe.

Carton image

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
37205-750-21	2025-04-25	C162847	48780-1	9d75b9d0-3b1a-f424-e053-dadaa90a57ce	Drug Facts
37205-750-21	2020-01-31	C162847	48780-1	9d75b9d0-3b1a-f424-e053-dadaa90a57ce	Drug Facts

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
37205-750-21	GM - Gram	37205-750	6e8deec0-d352-4d2a-8d5d-8d7be9253d2b	1	2013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
Trolamine Salicylate	ACTIVE INGREDIENT	H8O4040BHD	2
Trolamine	ACTIVE MOIETY	9O3K93S3TK	2
ALOE VERA LEAF	INACTIVE INGREDIENT	ZY81Z83H0X	2
Cetyl Alcohol	INACTIVE INGREDIENT	936JST6JCN	2
Glycerin	INACTIVE INGREDIENT	PDC6A3C0OX	2
Methylparaben	INACTIVE INGREDIENT	A2I8C7HI9T	2
Mineral Oil	INACTIVE INGREDIENT	T5L8T28FGP	2
POTASSIUM PHOSPHATE, DIBASIC	INACTIVE INGREDIENT	CI71S98N1Z	2
Propylparaben	INACTIVE INGREDIENT	Z8IX2SC1OH	2
Stearic Acid	INACTIVE INGREDIENT	4ELV7Z65AP	2
TROLAMINE	INACTIVE INGREDIENT	9O3K93S3TK	2
Water	INACTIVE INGREDIENT	059QF0KO0R	2

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

Arthritis Leader
Trolamine Salicylate
ALOE VERA LEAF
Cetyl Alcohol
Glycerin
Methylparaben
Mineral Oil
POTASSIUM PHOSPHATE, DIBASIC
Propylparaben
Stearic Acid
TROLAMINE
Water

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
37205-750	37205-750-21

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
ALOE VERA LEAF	ZY81Z83H0X	IACT
Cetyl Alcohol	936JST6JCN	IACT
Glycerin	PDC6A3C0OX	IACT
Methylparaben	A2I8C7HI9T	IACT
Mineral Oil	T5L8T28FGP	IACT
POTASSIUM PHOSPHATE, DIBASIC	CI71S98N1Z	IACT
Propylparaben	Z8IX2SC1OH	IACT
Stearic Acid	4ELV7Z65AP	IACT
TROLAMINE	9O3K93S3TK	IACT
Trolamine Salicylate	H8O4040BHD	ACTIB
Water	059QF0KO0R	IACT

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 6 · 328 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
Methylparaben	METHYLPARABEN	A2I8C7HI9T	ENEMA / RECTAL	0.18 %w/v		Exact identifier — unii candidate 79 equally ranked IID candidates
POTASSIUM PHOSPHATE, DIBASIC	DIBASIC POTASSIUM PHOSPHATE	CI71S98N1Z	INJECTION / INTRA-ARTICULAR	0.6 %w/v		Exact identifier — unii candidate 8 equally ranked IID candidates
Propylparaben	PROPYLPARABEN	Z8IX2SC1OH	CONCENTRATE / ORAL	2.5 mg/5ml		Exact identifier — unii candidate 68 equally ranked IID candidates
POTASSIUM PHOSPHATE, DIBASIC	DIBASIC POTASSIUM PHOSPHATE	CI71S98N1Z	SYRUP / ORAL	22 mg/5ml		Exact identifier — unii candidate 8 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	SHAMPOO, SUSPENSION / TOPICAL	0.15 %w/w		Exact identifier — unii candidate 79 equally ranked IID candidates
Propylparaben	PROPYLPARABEN	Z8IX2SC1OH	DROPS / AURICULAR (OTIC)	NA		Exact identifier — unii candidate 68 equally ranked IID candidates
Propylparaben	PROPYLPARABEN	Z8IX2SC1OH	OINTMENT / TOPICAL	0.2 %w/w		Exact identifier — unii candidate 68 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	SUSPENSION / OPHTHALMIC		58 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
Stearic Acid	STEARIC ACID	4ELV7Z65AP	CAPSULE / ORAL		90 mg	Exact identifier — unii candidate 26 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	SOLUTION / AURICULAR (OTIC)	63.64 %w/v		Exact identifier — unii candidate 75 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	INJECTION / INTRALESIONAL	0.15 %w/v		Exact identifier — unii candidate 79 equally ranked IID candidates
Propylparaben	PROPYLPARABEN	Z8IX2SC1OH	TABLET, EXTENDED RELEASE / ORAL	0.12 mg		Exact identifier — unii candidate 68 equally ranked IID candidates
Mineral Oil	MINERAL OIL	T5L8T28FGP	SYSTEM / TRANSDERMAL	6.09 mg		Exact identifier — unii candidate 30 equally ranked IID candidates
Propylparaben	PROPYLPARABEN	Z8IX2SC1OH	SOLUTION / INTRAVENOUS	0.02 %w/v		Exact identifier — unii candidate 68 equally ranked IID candidates
Mineral Oil	MINERAL OIL	T5L8T28FGP	SOAP / TOPICAL	0.82 %w/w		Exact identifier — unii candidate 30 equally ranked IID candidates
Mineral Oil	MINERAL OIL	T5L8T28FGP	CAPSULE, EXTENDED RELEASE / ORAL		120 mg	Exact identifier — unii candidate 30 equally ranked IID candidates
Propylparaben	PROPYLPARABEN	Z8IX2SC1OH	ENEMA / RECTAL	0.02 %w/w		Exact identifier — unii candidate 68 equally ranked IID candidates
TROLAMINE	TROLAMINE	9O3K93S3TK	GEL / TOPICAL		6 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	AEROSOL, FOAM / TOPICAL		21 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
Propylparaben	PROPYLPARABEN	Z8IX2SC1OH	SHAMPOO / TOPICAL	0.03 %w/w		Exact identifier — unii candidate 68 equally ranked IID candidates
Cetyl Alcohol	CETYL ALCOHOL	936JST6JCN	CREAM / VAGINAL		200 mg	Exact identifier — unii candidate 20 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	FILM, EXTENDED RELEASE / BUCCAL		34 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	LOTION / TOPICAL		351 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	SUSPENSION/ DROPS / ORAL		750 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
Mineral Oil	MINERAL OIL	T5L8T28FGP	SYSTEM / TOPICAL	654.36 mg		Exact identifier — unii candidate 30 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	FILM / BUCCAL		1 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
Propylparaben	PROPYLPARABEN	Z8IX2SC1OH	JELLY / NASAL	140 mg		Exact identifier — unii candidate 68 equally ranked IID candidates
Mineral Oil	MINERAL OIL	T5L8T28FGP	CREAM / VAGINAL		402 mg	Exact identifier — unii candidate 30 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	INJECTION, SOLUTION / PARENTERAL		30 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
Propylparaben	PROPYLPARABEN	Z8IX2SC1OH	SOLUTION/ DROPS / OPHTHALMIC	0.01 %w/v		Exact identifier — unii candidate 68 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	INJECTION, EMULSION / INTRAVENOUS		24100 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
Propylparaben	PROPYLPARABEN	Z8IX2SC1OH	INJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR	0.4 mg		Exact identifier — unii candidate 68 equally ranked IID candidates
Mineral Oil	MINERAL OIL	T5L8T28FGP	CAPSULE / ORAL		120 mg	Exact identifier — unii candidate 30 equally ranked IID candidates
Cetyl Alcohol	CETYL ALCOHOL	936JST6JCN	SUSPENSION / OPHTHALMIC	0.5 %w/v		Exact identifier — unii candidate 20 equally ranked IID candidates
Propylparaben	PROPYLPARABEN	Z8IX2SC1OH	LIQUID / TOPICAL	0.1 %w/w		Exact identifier — unii candidate 68 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	SUSPENSION/ DROPS / OPHTHALMIC	0.05 %w/w		Exact identifier — unii candidate 79 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	POWDER, FOR SUSPENSION / ORAL		75 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	TABLET, COATED / ORAL	0.8 mg		Exact identifier — unii candidate 79 equally ranked IID candidates
Stearic Acid	STEARIC ACID	4ELV7Z65AP	CAPSULE, EXTENDED RELEASE / ORAL		64 mg	Exact identifier — unii candidate 26 equally ranked IID candidates
Stearic Acid	STEARIC ACID	4ELV7Z65AP	CREAM / TOPICAL		190 mg	Exact identifier — unii candidate 26 equally ranked IID candidates
Mineral Oil	MINERAL OIL	T5L8T28FGP	SPRAY / TOPICAL		1379 mg	Exact identifier — unii candidate 30 equally ranked IID candidates
Mineral Oil	MINERAL OIL	T5L8T28FGP	OINTMENT / AURICULAR (OTIC)	NA		Exact identifier — unii candidate 30 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	INJECTION, SUSPENSION / INTRAMUSCULAR		1 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
TROLAMINE	TROLAMINE	9O3K93S3TK	AEROSOL, METERED / RECTAL	ADJ PH		Exact identifier — unii candidate 22 equally ranked IID candidates
Propylparaben	PROPYLPARABEN	Z8IX2SC1OH	OINTMENT / OPHTHALMIC	0.01 %w/w		Exact identifier — unii candidate 68 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	CONCENTRATE / ORAL		1800 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	SOLUTION / RECTAL	0.13 %w/v		Exact identifier — unii candidate 79 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS	225 mg		Exact identifier — unii candidate 75 equally ranked IID candidates
Cetyl Alcohol	CETYL ALCOHOL	936JST6JCN	CAPSULE, DELAYED RELEASE / ORAL		59 mg	Exact identifier — unii candidate 20 equally ranked IID candidates
Propylparaben	PROPYLPARABEN	Z8IX2SC1OH	GEL / TOPICAL		4 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	SOLUTION / INTRAVENOUS	0.13 %w/v		Exact identifier — unii candidate 79 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	INJECTION / INTRADERMAL	1 mg		Exact identifier — unii candidate 79 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	GEL / VAGINAL		8 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
Propylparaben	PROPYLPARABEN	Z8IX2SC1OH	CREAM / TOPICAL		6 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	SUSPENSION / AURICULAR (OTIC)	NA		Exact identifier — unii candidate 79 equally ranked IID candidates
Propylparaben	PROPYLPARABEN	Z8IX2SC1OH	TABLET, COATED / ORAL	0.8 mg		Exact identifier — unii candidate 68 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	ELIXIR / ORAL	800 mg		Exact identifier — unii candidate 79 equally ranked IID candidates
Stearic Acid	STEARIC ACID	4ELV7Z65AP	CREAM / VAGINAL		1088 mg	Exact identifier — unii candidate 26 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	INJECTION, SOLUTION / INTRAMUSCULAR		45 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
Propylparaben	PROPYLPARABEN	Z8IX2SC1OH	SPRAY / TOPICAL	0.8 %w/w		Exact identifier — unii candidate 68 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
9ac28454-83ad-4b71-bdd8-2c0cf7ac7699			14212b04-b9da-45c4-a009-02b9fb894130	2025-04-23	Warnings	Exact identifier spl set id: 14212b04-b9da-45c4-a009-02b9fb894130

Reported adverse events (FAERS/openFDA)#

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