ABC - TRIPLE ACTION ARTHRITIS CREAM (71049-101)

Manufacturer
WONG CHARKKEN BILL
Effective date
2023-02-06
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 21:37:41

Label at a glance#

ProductTRIPLE ACTION ARTHRITIS
Active ingredientMETHYL SALICYLATE, MENTHOL, CAPSAICIN
Label structure11 sections

Indications and uses

FOR THE TEMPORARY RELIEF OF MINOR ACHES AND PAINS OF MUSCLES AND JOINTS ASSOCIATED WITH: ARTHRITIS SPRAINS STRAINS BRUISES SIMPLE BACKACHE

Dosage and administration

ADULTS AND CHILDREN 12 YEARS OF AGE AND OVER APPLY TO THE AFFECTIVE AREA AND GENTLY RUB IT IN UNTIL FULLY ABSORBED REPEAT AS NECESSARY, BUT NOT MORE THAN 3 TO 4 TIMES DAILY UNLESS TREATING HANDS, WASH HANDS THOROUGHLY WITH SOAP AND WATER IMMEDIATELY AFTER USE CHILDREN UNDER 12 CONSULT A DOCTOR

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

METHYL SALICYLATE 28%

MENTHOL 10%

CAPSAICIN 0.025%

PURPOSE

OTC - PURPOSE SECTION

TOPICAL ANALGESIC

USES

INDICATIONS & USAGE SECTION

FOR THE TEMPORARY RELIEF OF MINOR ACHES AND PAINS OF MUSCLES AND JOINTS ASSOCIATED WITH:

  • ARTHRITIS
  • SPRAINS
  • STRAINS
  • BRUISES
  • SIMPLE BACKACHE

WARNINGS

WARNINGS SECTION

FOR EXTERNAL USE ONLY.

  • USE ONLY AS DIRECTED
  • DO NOT GET INTO EYES OR MUCOUS MEMBRANES
  • DO NOT APPLY TO WOUNDS OR DAMAGED, BROKEN OR IRRITATED SKIN
  • DO NOT TIGHTLY WRAP OR BANDAGE
  • DO NOT USE WITH A HEATING PAD
  • DO NOT EXPOSE THE TREATED AREA TO EXTERNAL HEAT OR DIRECT SUNLIGHT
  • A BURNING SENSATION MAY OCCUR UPON APPLICATION BUT GENERALLY DISAPPEARS IN A FEW DAYS WITH REGULAR USE

OTC - STOP USE SECTION

STOP USE AND ASK A DOCTOR IF

  • CONDITION WORSENS
  • EXCESSIVE BURNING OR IRRITATION PERSISTS
  • PAIN PERSISTS FOR MORE THAN 7 DAYS
  • SYMPTOMS CLEAR UP AND OCCUR AGAIN WITHIN A FEW DAYS

OTC - PREGNANCY OR BREAST FEEDING SECTION

IF PREGNANT OR BREAST FEEDING, ASK A HEALTH PROFESSIONAL BEFORE USE.

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 RIGHT AWAY

DIRECTIONS:

DOSAGE & ADMINISTRATION SECTION

ADULTS AND CHILDREN 12 YEARS OF AGE AND OVER

  • APPLY TO THE AFFECTIVE AREA AND GENTLY RUB IT IN UNTIL FULLY ABSORBED
  • REPEAT AS NECESSARY, BUT NOT MORE THAN 3 TO 4 TIMES DAILY
  • UNLESS TREATING HANDS, WASH HANDS THOROUGHLY WITH SOAP AND WATER IMMEDIATELY AFTER USE

CHILDREN UNDER 12

  • CONSULT A DOCTOR

OTHER INFORMATION:

OTHER SAFETY INFORMATION

STORE AT ROOM TEMPARATURE

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

Acrylates/C10-30alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf Juice, Benzoic Acid, Boswellia Serrata Gum, Cetear yl Alcohol, Ethylhexylglycerin, Gaultheria Procumbens (Wintergreen) Leaf Extract, Glycereth-2 Cocoate, Glycer yl Stearate, Hydroxypropyl
Methyl Cellulose, Isopropyl Palmitate, Peg-100 Stearate, Petasites Vulgaris Leaf Extract, Phenoxyethanol, Polysorbate 60, Propylene Glycol, Salix Alba (Willow) Bark Extract, Stearyl Alcohol, Zanthoxylum Americanum Bark Extract, Pinus Pinaster Bark/Bud Extract, Water, Zingiber
Officinale (Ginger) Root Extract.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

FDA-Initiated Inactive NDC Indexing#

Products#

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NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71049-10171049-101-12

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 25 matching rows.

Source Document#

Source XML

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
14ab4cdd-0356-8169-e063-6394a90a58af9fd0f54a-30bb-41d1-84db-7b1be738644d2024-03-27WarningsExact identifier
spl set id: 9fd0f54a-30bb-41d1-84db-7b1be738644d

Reported adverse events (FAERS/openFDA)#

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