Proflexa by Sinoveda Canada Inc / Ec Labs Inc PROFLEXA- camphor cream

Proflexa by

Drug Labeling and Warnings

Proflexa by is a Otc medication manufactured, distributed, or labeled by Sinoveda Canada Inc, Ec Labs Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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:

• Simple Backache
• Arthritis
• Strains
• Bruises
• Sprains

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

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)

INGREDIENTS AND APPEARANCE

PROFLEXA 
camphor cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83011-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941)	CAMPHOR (NATURAL)	3.3 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83011-001-01	1 in 1 CARTON	09/30/2022
1		50 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	09/30/2022

Labeler - Sinoveda Canada Inc (242335052)

Establishment
Name	Address	ID/FEI	Business Operations
Ec Labs Inc		205510751	manufacture(83011-001)