Labella Linimento Obrero
FDA Label NDC 31774-8005

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Golden Sun Inc Dba Newhall Laboratories for the product Labella Linimento Obrero (NDC 31774-8005). 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, otc - purpose, use, otc - keep out of reach of children, when using this product, directions, inactive ingredients, questions?, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

Distributed by
Newhall Laboratories, Inc.
5 High Ridge Park, Suite 100
Stamford, CT 06905

Otc - Purpose

Active IngredientsPurpose
Capsaicin 0.025%Topical Analgesic
Menthol 2.0%Topical Analgesic
Methyl Salicylate 10%Topical Analgesic

Use

  • Temporarily relieves the minor aches and pains of muscle and joints.

Otc - Keep Out Of Reach Of Children

  • For external use only.
  • Keep this and all other drugs out of the reach of children.
  • If swallowed, get medical help or contact a Poison Control Center immediately.

When Using This Product

  • Avoid contact with eyes.
  • Do not bandage tightly.
  • Do not apply to wounds or broken skin.
  • If condition worsens or if symptoms persist for more than 7 days, discontinue use of this product and consult a physician.

Directions

  • Use only as directed.
  • Adults and children 2 years of age or older: apply to affected area not more than 3 to 4 times daily.
  • Children under 2 years of age: consult a physician.

Inactive Ingredients

Water (Aqua), Stearic Acid, Isopropyl Palmitate, Propylene Glycol, Cetyl Alcohol, Glyceryl Monostearate, Thiethanolamine, Stearyl Alcohol, Polysorbate 60, Phenoxyethanol, Carbomer, Methylparaben, Propylparaben, Sorbitan Sesquioleate, Tetra Sodium EDTA.

Questions?

www.labellabeauty.com

Principal Display Panel - 236 Ml Bottle Label

LA BELLA™

LINIMENTO
OBRERO

Pain Relieving Cream
with Chile Extract

Relieves minor aches & pains

Net Wt. 8 FL. OZ. (236 ml)

Principal Display Panel (236 ml Bottle Label)

Principal Display Panel (236 ml Bottle Label)

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