FDA.reportPublic FDA data

Analgesic Balm

Manufacturer
Geri-Care Pharmaceuticals, Corp | Trifecta Pharmaceuticals USA LLC.
Effective date
2025-11-18
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 01:16:49

Label at a glance#

ProductAnalgesic Balm
Active ingredientMENTHOL, METHYL SALICYLATE
Label structure13 sections

Dosage and administration

Use only as directed Adults and children 12 years of age or older. Apply to the affected area not more than 3 to 4 times daily. Children under 12 years of age. consult a doctor Unless treating hands, wash hands thoroughly with soap and water immediately after use.

Storage and handling

Store at controlled room temperature 20º-25ºC (68º-77ºF) Questions ? Call 1-800-540-3765

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Menthol 10%

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Methyl Salicylate 15%

OTC - PURPOSE SECTION

Topical Analgesic

INDICATIONS & USAGE SECTION

For the temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises and sprains

Warnings

WARNINGS SECTION

For external use only

Do not use:

  • On wounds or damaged, broken (open) or irritated skin
  • On a child under 12 years of age with arthritis-like conditions
  • With a heating pad

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

When using this product

  • Avoid contact with eyes or mucous membranes
  • Do not bandage tightly

Stop Use and ask a doctor

OTC - STOP USE SECTION

  • Conditions worsens or does not improve within 7 days
  • Symptoms clear up and occur again within a few days
  • Excessive skin irritation develops

Keep out of the reach of Children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • Use only as directed
  • Adults and children 12 years of age or older. Apply to the affected area not more than 3 to 4 times daily.

Children under 12 years of age. consult a doctor

  • Unless treating hands, wash hands thoroughly with soap and water immediately after use.

Other Information

STORAGE AND HANDLING SECTION

  • Store at controlled room temperature 20º-25ºC (68º-77ºF)

Questions ? Call 1-800-540-3765

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Carbomer 940, Cetyl alcohol, Glycerol, Glyceryl monostearate, Methylparaben, Polysorbate 80, Propylparaben, Purified Water, Stearic acid, Trolamine

Distributed By

SPL UNCLASSIFIED SECTION

Distributed By

GeriCare Pharmaceuticals

1650 63rd Street

Brooklyn, NY 11204

Made in China

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

GERICARE TOPICAL ANALGESIC CREAM 1OZ REV1224 CDERGERICARE TOPICAL ANALGESIC CREAM 1OZ REV1224 CDER

Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

GERICARE TOPICAL ANALGESIC CREAM 3OZ REV1224 CDERGERICARE TOPICAL ANALGESIC CREAM 3OZ REV1224 CDER

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
311498menthol 10 % / methyl salicylate 15 % Topical CreamPSN6
311498menthol 100 MG/ML / methyl salicylate 150 MG/ML Topical CreamSCD6
311498menthol 10 % / methyl salicylate 15 % Topical CreamSY6
311498menthol 10 GM / methyl salicylate 15 GM per 100 GM Topical CreamSY6

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130357896116019GTIN-13: 0357896116019
EAN-13: 0357896116019
GTIN-12: 357896116019
UPC-A: 357896116019
GTIN storage (14 digits): 00357896116019		GERICARE TOPICAL ANALGESIC CREAM 1OZ REV1224 CDER.jpg
BarcodeEAN-130357896116033GTIN-13: 0357896116033
EAN-13: 0357896116033
GTIN-12: 357896116033
UPC-A: 357896116033
GTIN storage (14 digits): 00357896116033		GERICARE TOPICAL ANALGESIC CREAM 3OZ REV1224 CDER.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57896-116-03Analgesic Balm85 g in 1 TUBECREAM856
57896-116-03Analgesic Balm1 in 1 BOXCREAM16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
57896-116-01GM - Gram57896-116eb00359e-6779-4d5d-889f-faf01a0aef3a12022-03-09
57896-116-03GM - Gram57896-1168d140034-fadf-497b-b76d-6eaf558392dd12022-03-09

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
57896-11657896-116-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
POLYSORBATE 806OZP39ZG8HIACT
TROLAMINE9O3K93S3TKIACT
CARBOMER 9404Q93RCW27EIACT
CETYL ALCOHOL936JST6JCNIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
METHYLPARABENA2I8C7HI9TIACT
WATER059QF0KO0RIACT
STEARIC ACID4ELV7Z65APIACT
GLYCERINPDC6A3C0OXIACT
MENTHOLL7T10EIP3AACTIB
METHYL SALICYLATELAV5U5022YACTIB
PROPYLPARABENZ8IX2SC1OHIACT

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Analgesic BalmMENTHOL 10%, METHYL SALICYLATE 15%Geri-Care Pharmaceuticals, Corpc8594e10-661f-6ff3-e053-2995a90ab4fc2025-11-18WarningsExact identifier
ndc (package): 57896-116-03
ndc (product): 57896-116
ndc11 (package): 57896011603
spl id: 43e02980-58b7-7991-e063-6294a90a7a29
spl set id: c8594e10-661f-6ff3-e053-2995a90ab4fc
Analgesic BalmMENTHOL 10%, METHYL SALICYLATE 15%Geri-Care Pharmaceuticals, Corpab9bf09d-bc8c-6d17-e053-2995a90a6c362024-02-14WarningsExact identifier
ndc (product): 57896-116

Reported adverse events (FAERS/openFDA)#

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