Retadolor
FDA Label NDC 69279-144

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Lacar Sales & Marketing Inc. for the product Retadolor (NDC 69279-144). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, active ingredient, purpose, uses, warnings, otc - when using, flammable, otc - ask doctor, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

Active Ingredient

Capsicum Oleoresin 0.0625% (Containing Capsaicin 0.025%)

Purpose

Pain Relieving

Uses

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

  • simple backache
  • arthritis
  • strains
  • sprains
  • bruises

Warnings

For external use only.

  • do not apply to wounds or damaged skin
  • do not bandage tightly

Otc - When Using

When using this product do not get into eyes

  • avoid contact with other mucous membranes

Flammable

Keep from heat and flame.

Otc - Ask Doctor

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

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.

  • if swallowed, get medical help or contact a Poison Control center right away

Otc - Pregnancy Or Breast Feeding

  • if pregnant or nursing, seek the advice of a health professional before using

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

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)

Principal Display Panel (85 g Bottle Label)

Principal Display Panel (85 g Bottle Label)

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