PROFLEXA- camphor cream 
Sinoveda Canada Inc

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

Proflexa

Active ingredient

Camphor 3.3%

Purpose

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

Uses

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

Warnings

For external use only

When using this product

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

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

If pregnant or breastfeeding, ask a health professional before use.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

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 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

Proflexa

Botanical Pain Relief Cream for Muscles and Joints

Camphor 3.3%

NDC #: 83011-001-01

Radiate Freedom

Net Wt 1.76 oz (50g)

2

3

1

PROFLEXA 
camphor cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83011-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941) CAMPHOR (NATURAL)3.3 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
SAFFLOWER (UNII: 4VBL71TY4Y)  
CETEARYL OLIVATE (UNII: 58B69Q84JO)  
CITRUS PARADISI SEED (UNII: 12F08874Y7)  
MYRRH (UNII: JC71GJ1F3L)  
GLYCERIN (UNII: PDC6A3C0OX)  
GLYCERYL STEARATE CITRATE (UNII: WH8T92A065)  
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
LIGUSTICUM SINENSE SUBSP. CHUANXIONG ROOT (UNII: RR83T99U97)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
GRAPE SEED OIL (UNII: 930MLC8XGG)  
XANTHAN GUM (UNII: TTV12P4NEE)  
ANGELICA POLYMORPHA ROOT (UNII: HZ12173363)  
BOSWELLIA SACRA WHOLE (UNII: 8O600AZL0W)  
SHEA BUTTER (UNII: K49155WL9Y)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
CLOVE OIL (UNII: 578389D6D0)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:83011-001-011 in 1 CARTON09/30/2022
150 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34809/30/2022
Labeler - Sinoveda Canada Inc (242335052)
Establishment
NameAddressID/FEIBusiness Operations
Ec Labs Inc205510751manufacture(83011-001)

Revised: 9/2022
Document Id: e9ebcd18-e22a-78b0-e053-2995a90acd1f
Set id: e9ebcd18-e229-78b0-e053-2995a90acd1f
Version: 1
Effective Time: 20220930
 
Sinoveda Canada Inc