FDA.reportPublic FDA data

Proflexa

Manufacturer
Sinoveda Canada Inc | Ec Labs Inc
Effective date
2022-09-30
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:51:12

Label at a glance#

ProductProflexa
Active ingredientCAMPHOR (NATURAL)
Label structure9 sections

Indications and uses

For the temporary relief of the minor aches and pains of muscles and joints associated with: Simple Backache Arthritis Strains Bruises Sprains

Dosage and administration

Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily Children under 2 years of age: Consult a doctor

Storage and handling

Store in a cool, dry place away from light

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Camphor 3.3%

Purpose

OTC - PURPOSE SECTION

Camphor 3.3%......................Topical Analgesic

Uses

INDICATIONS & USAGE SECTION

For the temporary relief of the minor aches and pains of muscles and joints associated with:

  • Simple Backache
  • Arthritis
  • Strains
  • Bruises
  • Sprains

Warnings

WARNINGS SECTION

For external use only

OTC - WHEN USING SECTION

When using this product

  • Avoid contact with eyes
  • Do not apply to wounds or damaged skin
  • Do not bandage tightly

OTC - STOP USE SECTION

Stop use and ask doctor if

  • Condition worsens
  • Irritation occurs
  • Symptoms persist for more than 7 days or clear up and occur again within a few days

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breastfeeding, 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 2 years of age and older: Apply to affected area not more than 3 to 4 times daily

Children under 2 years of age: Consult a doctor

Other information

STORAGE AND HANDLING SECTION

Store in a cool, dry place away from light

Inactive ingredients

INACTIVE INGREDIENT SECTION

Angelica Polymorpha Sinensis Root Extract, Boswellia Sacra (Frankincense) Gum/Resin Extract, Butyrospermum Parkii (Shea) Butter, Caprylic/Capric Triglyceride, Carthamus Tinctorius (Safflower) Flower Extract, Cetearyl Olivate, Citrus Paradisi (Grapefruit) Seed Extract, Commiphora Myrrha Resin Extract, Eugenia Caryophyllus (Clove) Flower Oil, Glycerin, Glyceryl Stearate Citrate, Isopropyl Palmitate, Ligusticum Chuanxiong Root Extract, Sodium Benzoate, Sodium Hyaluronate, Stearyl Alcohol, Vitis Vinifera (Grape) Seed Oil, Xanthan Gum

Questions or comments?

OTC - QUESTIONS SECTION

1-780-466-0086 Mon-Fri 9am-5pm MST

954-414-0380

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Proflexa

Botanical Pain Relief Cream for Muscles and Joints

Camphor 3.3%

NDC #: 83011-001-01

Radiate Freedom

Net Wt 1.76 oz (50g)

22

33

11

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2619330camphor 3.3 % Topical CreamPSN1
2619335PROFLEXA 3.3 % Topical CreamPSN1
2619335camphor 33 MG/ML Topical Cream [Proflexa]SBD1
2619330camphor 33 MG/ML Topical CreamSCD1
2619330camphor 3.3 % Topical CreamSY1
2619335Proflexa 3.3 % Topical CreamSY1
2619335Proflexa 33 MG/ML Topical CreamSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
83011-001-012024-07-30C16284748780-11030e365-328e-111a-e063-dadaa90a10e2Proflexa
83011-001-012024-01-30C16284748780-11030e365-328e-111a-e063-dadaa90a10e2Proflexa

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83011-001-01Proflexa1 in 1 CARTONCREAM11
83011-001-01Proflexa50 g in 1 TUBECREAM501

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83011-001PROFLEXA (CAMPHOR) CREAM [SINOVEDA CANADA INC]1Legacy NDC, 2 package rows20221027_e9ebcd18-e229-78b0-e053-2995a90acd1f.zip

Products#

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

DailyMed product names page 1 of 1 · 21 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83011-00183011-001-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 19 matching rows.

Name, UNII, Kind table
NameUNIIKind
SAFFLOWER4VBL71TY4YIACT
CETEARYL OLIVATE58B69Q84JOIACT
CITRUS PARADISI SEED12F08874Y7IACT
MYRRHJC71GJ1F3LIACT
GLYCERINPDC6A3C0OXIACT
GLYCERYL STEARATE CITRATEWH8T92A065IACT
ISOPROPYL PALMITATE8CRQ2TH63MIACT
LIGUSTICUM SINENSE SUBSP. CHUANXIONG ROOTRR83T99U97IACT
SODIUM BENZOATEOJ245FE5EUIACT
HYALURONATE SODIUMYSE9PPT4THIACT
STEARYL ALCOHOL2KR89I4H1YIACT
GRAPE SEED OIL930MLC8XGGIACT
XANTHAN GUMTTV12P4NEEIACT
ANGELICA POLYMORPHA ROOTHZ12173363IACT
BOSWELLIA SACRA WHOLE8O600AZL0WIACT
SHEA BUTTERK49155WL9YIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
CAMPHOR (NATURAL)N20HL7Q941ACTIB
CLOVE OIL578389D6D0IACT

Source Document#

Source XML

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

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

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
e9ebcd18-e22a-78b0-e053-2995a90acd1fe9ebcd18-e229-78b0-e053-2995a90acd1f2022-09-30WarningsExact identifier
spl id: e9ebcd18-e22a-78b0-e053-2995a90acd1f
spl set id: e9ebcd18-e229-78b0-e053-2995a90acd1f