Retadolor™

Retadolor™
SPL v1
SPL
SPL Set ID a97aa83b-2673-4edc-b7ed-319591a0a940
Route
TOPICAL
Published
Effective Date 2015-08-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Capsaicin (0.25 mg)
Inactive Ingredients
Water Arnica Montana Flower Methyl Diisopropyl Propionamide Lauryl Laurate Phenoxyethanol Dmdm Hydantoin Iodopropynyl Butylcarbamate Aloe Vera Leaf Menthyl Lactate, (-)- Starch, Corn Ppg-2 Hydroxyethyl Cocamide Trolamine Alcohol Peppermint Oil Linseed Oil Acai Oil Ethyl Menthane Carboxamide Rosemary Oil

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2015-08-07

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 50567-7

When using this product do not get into eyes

  • avoid contact with other mucous membranes
Section 50569-3

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 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
Flammable

Keep from heat and flame.

Directions
  • Apply a thin layer to affected area not more than 4 times daily unless otherwise directed by your physician or pharmacist
  • 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), SD Alcohol 40-B, Aloe Barbadensis Leaf Juice, Mentha Piperita (Peppermint) Oil, Arnica Montana Flower Extract, Acrylates Copolymer, Linum Usitatissmum (Linseed) Seed Oil, Euterpe Oleracea Fruit Oil, PPG-2 Hydroxyethyl Cocamide, Rosmarinus Officinalis (Rosemary) Leaf Oil, Methyl Diisopropyl Propionamide, Ethyl Menthane Carboxamide, Menthyl Lactate, Lauryl Laurate, Zea Mays (Corn) Starch, Hydrolyzed Corn Starch, Hydrolyzed Starch Octenylsuccinate, Acrylates C10-30 Alkyl Acrylate Crosspolymer, Triethanolamine, Phenoxyethanol, DMDM Hydantoin, Iodopropynyl Butylcarbamate.

Principal Display Panel 85 G Bottle Label

RETADOLOR

The Anti-Pain

PENETRATING HEAT THERAPY CREAM

Topical Analgesic for the Relief of

ARTHRITIS, JOINT PAIN, MUSCLE

ACHES AND CRAMPS

#1

Contains

Capsaicin

Recommended

by Doctors

ANTI-INFLAMMATORY

OMEGA

3, 6 & 9

with

IcePearls

NET WT 3 OZ. (85g)


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 50567-7 (50567-7)

When using this product do not get into eyes

  • avoid contact with other mucous membranes
Section 50569-3 (50569-3)

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 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
Flammable

Keep from heat and flame.

Directions
  • Apply a thin layer to affected area not more than 4 times daily unless otherwise directed by your physician or pharmacist
  • 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), SD Alcohol 40-B, Aloe Barbadensis Leaf Juice, Mentha Piperita (Peppermint) Oil, Arnica Montana Flower Extract, Acrylates Copolymer, Linum Usitatissmum (Linseed) Seed Oil, Euterpe Oleracea Fruit Oil, PPG-2 Hydroxyethyl Cocamide, Rosmarinus Officinalis (Rosemary) Leaf Oil, Methyl Diisopropyl Propionamide, Ethyl Menthane Carboxamide, Menthyl Lactate, Lauryl Laurate, Zea Mays (Corn) Starch, Hydrolyzed Corn Starch, Hydrolyzed Starch Octenylsuccinate, Acrylates C10-30 Alkyl Acrylate Crosspolymer, Triethanolamine, Phenoxyethanol, DMDM Hydantoin, Iodopropynyl Butylcarbamate.

Principal Display Panel 85 G Bottle Label (PRINCIPAL DISPLAY PANEL - 85 g Bottle Label)

RETADOLOR

The Anti-Pain

PENETRATING HEAT THERAPY CREAM

Topical Analgesic for the Relief of

ARTHRITIS, JOINT PAIN, MUSCLE

ACHES AND CRAMPS

#1

Contains

Capsaicin

Recommended

by Doctors

ANTI-INFLAMMATORY

OMEGA

3, 6 & 9

with

IcePearls

NET WT 3 OZ. (85g)


Advanced Ingredient Data


Raw Label Data

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