Omega 3 Cream

Omega 3 Cream
SPL v1
SPL
SPL Set ID 9eff27c6-d961-49e4-9cee-74673c692b8f
Route
TOPICAL
Published
Effective Date 2016-09-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Capsaicin (2.5 mg)
Inactive Ingredients
Water Aloe Vera Leaf Methyl Diisopropyl Propionamide Ethyl Menthane Carboxamide Menthyl Lactate, (-)- Lauryl Laurate Starch, Corn Hydrated Silica Glucosamine Hydrochloride Dimethyl Sulfone Glycerin Sunflower Oil Alfalfa Arnica Montana Flower Cymbopogon Schoenanthus Top Rosemary Mentha Piperita Leaf Asian Ginseng Ginkgo Flax Seed Celosia Argentea Seed Acai Edetate Disodium Emu Oil Polysorbate 20 .alpha.-tocopherol Acetate Butylene Glycol Phenoxyethanol Caprylyl Glycol Ethylhexylglycerin Hexylene Glycol Cetearyl Isononanoate Polyoxyl 20 Cetostearyl Ether Cetostearyl Alcohol Glyceryl Monostearate Ceteareth-12 Cetyl Palmitate Sodium Hydroxide

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2016-07-08

Description

Drug Facts

Purpose

Pain Relieving


Medication Information

Purpose

Pain Relieving

Description

Drug Facts

Uses

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

  • simple backache
  • arthritis
  • strains
  • sprains
  • bruises
Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children.

  • if swallowed, get medical help or contact a Poison Control center right away
Section 50566-9

Discontinue use and ask a doctor if condition worsens or if symptoms persist for more than 7 days or clear up and occur again within a few days.

Section 50567-7

When using this product do not get into eyes

  • avoid contact with other mucous membranes
Section 53414-9
  • if pregnant or nursing, seek the advice of a health professional before using
Warnings

For external use only.

  • do not apply to wounds or damaged skin
  • do not bandage tightly
  • do not use with heating pad, pack, wrap, hot water bottle or any heating element
Directions
  • Children under 12 years of age consult a physician
  • Apply a thin layer to affected area not more than 3 to 4 times daily
  • Gently massage into the skin until fully absorbed
  • Wash hands with soap and water after each application to avoid spreading to the eyes or other sensitive mucous membranes
Active Ingredient

Capsicum Oleoresin 0.0625% (Containing Capsaicin 0.025%)

Inactive Ingredients

Water (Aqua), Butylene Glycol, Glycerin, Aloe Barbadensis Leaf Juice, Helianthus Annuus (Sunflower) Seed Oil, Medicago Sativa (Alfalfa) Extract, Arnica Montana Flower Extract, Cymbopogon Schoenanthus Stem/Leaf/Flower Extract, Rosmarinus Officinalis (Rosemary) Leaf Extract, Mentha Piperita (Peppermint) Leaf Extract, Panax Ginseng Root Extract, Ginkgo Biloba Leaf Extract, Linum Usitatissimum (Linseed ) Seed Extract, Celosia Argentea Seed Extract, Euterpe Oleracea Fruit Extract, Mentha Piperita Leaf Extract, Glucosamine HCl, Dimethyl Sulfone, Hydrolyzed Corn Starch, Lauryl Laurate, Methyl Diisopropyl Propionamide, Ethyl Menthane Carboxamide, Menthyl Lactate, Hydrated Silica, Zea Mays (Corn) Starch, Hydrolyzed Corn Starch Octenylsuccinate, Cetearyl Isononanoate, Ceteareth-20, Cetearyl Alcohol, Glyceryl Stearate, Ceteareth-12, Cetyl Palmitate, Emu Oil, Polysorbate 20, Acrylates/C 10-30 Alkyl Acrylate Crosspolymer, Tocopheryl Acetate, Disodium EDTA, Phenoxyethanol, Caprylyl Glycol, Ethylhexylglycerin, Hexylene Glycol, Sodium Hydroxide.

Questions Or Comments?

Call 1-888-373-8831

Principal Display Panel 59 Ml Bottle Label

OMEGA

3

PAIN RELIEVING CREAM

Fast, Long-Lasting Relief

for Muscle & Joint Pain

with Omega-3 Fatty Acids

Also contains

MSM, Glucosamine

& Capsaicin

  • Powerful Anti-Inflammatory
  • Soothing Nutritive Abilities
  • Natural Antioxidant Protection
  • Safe Alternative to Pills

2 FL OZ (59mL)


Structured Label Content

Uses

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

  • simple backache
  • arthritis
  • strains
  • sprains
  • bruises
Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children.

  • if swallowed, get medical help or contact a Poison Control center right away
Section 50566-9 (50566-9)

Discontinue use and ask a doctor if condition worsens or if symptoms persist for more than 7 days or clear up and occur again within a few days.

Section 50567-7 (50567-7)

When using this product do not get into eyes

  • avoid contact with other mucous membranes
Section 53414-9 (53414-9)
  • if pregnant or nursing, seek the advice of a health professional before using
Purpose

Pain Relieving

Warnings

For external use only.

  • do not apply to wounds or damaged skin
  • do not bandage tightly
  • do not use with heating pad, pack, wrap, hot water bottle or any heating element
Directions
  • Children under 12 years of age consult a physician
  • Apply a thin layer to affected area not more than 3 to 4 times daily
  • Gently massage into the skin until fully absorbed
  • Wash hands with soap and water after each application to avoid spreading to the eyes or other sensitive mucous membranes
Active Ingredient (Active ingredient)

Capsicum Oleoresin 0.0625% (Containing Capsaicin 0.025%)

Inactive Ingredients (Inactive ingredients)

Water (Aqua), Butylene Glycol, Glycerin, Aloe Barbadensis Leaf Juice, Helianthus Annuus (Sunflower) Seed Oil, Medicago Sativa (Alfalfa) Extract, Arnica Montana Flower Extract, Cymbopogon Schoenanthus Stem/Leaf/Flower Extract, Rosmarinus Officinalis (Rosemary) Leaf Extract, Mentha Piperita (Peppermint) Leaf Extract, Panax Ginseng Root Extract, Ginkgo Biloba Leaf Extract, Linum Usitatissimum (Linseed ) Seed Extract, Celosia Argentea Seed Extract, Euterpe Oleracea Fruit Extract, Mentha Piperita Leaf Extract, Glucosamine HCl, Dimethyl Sulfone, Hydrolyzed Corn Starch, Lauryl Laurate, Methyl Diisopropyl Propionamide, Ethyl Menthane Carboxamide, Menthyl Lactate, Hydrated Silica, Zea Mays (Corn) Starch, Hydrolyzed Corn Starch Octenylsuccinate, Cetearyl Isononanoate, Ceteareth-20, Cetearyl Alcohol, Glyceryl Stearate, Ceteareth-12, Cetyl Palmitate, Emu Oil, Polysorbate 20, Acrylates/C 10-30 Alkyl Acrylate Crosspolymer, Tocopheryl Acetate, Disodium EDTA, Phenoxyethanol, Caprylyl Glycol, Ethylhexylglycerin, Hexylene Glycol, Sodium Hydroxide.

Questions Or Comments? (Questions or comments?)

Call 1-888-373-8831

Principal Display Panel 59 Ml Bottle Label (PRINCIPAL DISPLAY PANEL - 59 mL Bottle Label)

OMEGA

3

PAIN RELIEVING CREAM

Fast, Long-Lasting Relief

for Muscle & Joint Pain

with Omega-3 Fatty Acids

Also contains

MSM, Glucosamine

& Capsaicin

  • Powerful Anti-Inflammatory
  • Soothing Nutritive Abilities
  • Natural Antioxidant Protection
  • Safe Alternative to Pills

2 FL OZ (59mL)


Advanced Ingredient Data


Raw Label Data

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