FDA.reportPublic FDA data

Quality Choice Ultra Strength Pain Relieving Cream

Manufacturer
QUALITY CHOICE (Chain Drug Marketing Association) | ANICARE PHARMACEUTICALS PRIVATE LIMITED
Effective date
2024-12-18
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:44:56

Label at a glance#

ProductQuality Choice Ultra Strength Pain Relieving Cream Ultra Strength
Active ingredientCAMPHOR (NATURAL), MENTHOL, UNSPECIFIED FORM, METHYL SALICYLATE
Label structure9 sections

Indications and uses

temporarily relieves minor aches and pains of muscles and joints associated with: simple backache arthritis strains sprains bruises

Dosage and administration

adults and children 12 years and over; apply to affected area not more than 3 to 4 times daily children under 12 years of age; consult a physician

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Camphor 4%

Menthol 10%

Methyl salicylate 30%

Purpose

OTC - PURPOSE SECTION

Camphor - Topical analgesic

Menthol - Topical analgesic

Methyl salicylate - Topical analgesic

Uses

INDICATIONS & USAGE SECTION

temporarily relieves minor aches and pains of muscles and joints associated with:

  • simple backache
  • arthritis
  • strains
  • sprains
  • bruises

Warnings

WARNINGS SECTION

For external use only

Do not Use

OTC - DO NOT USE SECTION

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

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

redness over the affected area

When using this product

OTC - WHEN USING SECTION

  • use only as directed
  • avoid contact with eyes or mucous membranes
  • do not bandage tightly

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • skin redness or excessive irritation of the skin occurs
  • condition worsens
  • symptoms persist for more than 7 days or clear up and occur again within a few days

Keep Out of Reach of Children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away (1-800-222-1222)

Directions

DOSAGE & ADMINISTRATION SECTION

  • adults and children 12 years and over; apply to affected area not more than 3 to 4 times daily
  • children under 12 years of age; consult a physician

Other Information

OTHER SAFETY INFORMATION

  • Store at 20-25 C (68-77F)
  • do not use if tube seal under cap is broken

Inactive Ingredients

INACTIVE INGREDIENT SECTION

carbomer homopolymer type c, cetostearyl alcohol, cetyl alcohol, glyceryl monostearate, methylparaben, peg-100 stearate, polysorbate 60, propylparaben, stearic acid, trolamine, water

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
283083camphor 4 % / menthol 10 % / methyl salicylate 30 % Topical CreamPSN2
283083camphor 40 MG/ML / menthol 100 MG/ML / methyl salicylate 300 MG/ML Topical CreamSCD2
283083camphor 4 % / menthol 10 % / methyl salicylate 30 % Topical CreamSY2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63868-692-042025-07-29C16284748780-13b156c62-3465-fb37-e063-e6dba90a4e07Quality Choice Ultra Strength Pain Relieving Cream

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63868-692-04Quality Choice Ultra Strength Pain Relieving CreamUltra Strength1 in 1 CARTONCREAM12
63868-692-04Quality Choice Ultra Strength Pain Relieving CreamUltra Strength113 g in 1 TUBECREAM1132

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63868-692QUALITY CHOICE ULTRA STRENGTH PAIN RELIEVING CREAM ULTRA STRENGTH (CAMPHOR, MENTHOL, METHYL SALICYLATE) CREAM [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]2Legacy NDC, 2 package rows20241220_be62b6ea-09ac-0d4b-e053-2a95a90ada65.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63868-692-04GM - Gram63868-692da4685f6-88f7-4e71-bacf-936f90192c7712021-05-05

Products#

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

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

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63868-69263868-692-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)4Q93RCW27EIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
CETYL ALCOHOL936JST6JCNIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
POLYOXYL 100 STEARATEYD01N1999RIACT
POLYSORBATE 60CAL22UVI4MIACT
WATER059QF0KO0RIACT
METHYLPARABENA2I8C7HI9TIACT
STEARIC ACID4ELV7Z65APIACT
TROLAMINE9O3K93S3TKIACT
PROPYLPARABENZ8IX2SC1OHIACT
CAMPHOR (NATURAL)N20HL7Q941ACTIB
MENTHOL, UNSPECIFIED FORML7T10EIP3AACTIB
METHYL SALICYLATELAV5U5022YACTIB

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
29946ce0-9f9e-b43f-e063-6394a90a43babe62b6ea-09ac-0d4b-e053-2a95a90ada652024-12-18WarningsExact identifier
spl id: 29946ce0-9f9e-b43f-e063-6394a90a43ba
spl set id: be62b6ea-09ac-0d4b-e053-2a95a90ada65

Reported adverse events (FAERS/openFDA)#

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