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

Key Label Information#

Active Ingredients And Purpose

Active ingredient

Camphor 3.3%

Purpose

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

Uses

Uses

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

Warnings

Warnings

For external use only

Directions And Dosage

Directions

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 Label Information

Other information

Store in a cool, dry place away from light

Inactive ingredients

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?

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)

Label Images#

Proflexa US Label changes pending (V3)-page-002
Proflexa US Label changes pending (V3)-page-002
Proflexa US Label changes pending (V3)-page-003
Proflexa US Label changes pending (V3)-page-003
Proflexa US Label changes pending (V3)-page-001
Proflexa US Label changes pending (V3)-page-001

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#

NDC Codes#

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

Ingredients#

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

Complete SPL Sections#

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

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

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)

Source Document#

Source XML