OTC Medication Information: LaBella Linimento Obrero

LABELLA LINIMENTO OBRERO- capsaicin, menthol, unspecified form and methyl salicylate cream
Golden Sun Inc DBA Newhall Laboratories

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Facts

Active Ingredients Purpose
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.

Warnings

  • 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

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

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
(click image for full-size original)
LABELLA LINIMENTO OBRERO
capsaicin, menthol, unspecified form, and methyl salicylate cream
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:31774-8005
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Capsaicin (Capsaicin) Capsaicin 0.25 mg in 1 mL
Menthol, Unspecified Form (Menthol, Unspecified Form) Menthol, Unspecified Form 20 mg in 1 mL
Methyl Salicylate (Salicylic Acid) Methyl Salicylate 100 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
Water
Stearic Acid
Isopropyl Palmitate
Propylene Glycol
Cetyl Alcohol
Glyceryl Monostearate
Stearyl Alcohol
Polysorbate 60
Phenoxyethanol
Methylparaben
Propylparaben
Sorbitan Sesquioleate
Edetate Sodium
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:31774-8005-1 236 mL in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part346 01/02/2013
Labeler — Golden Sun Inc DBA Newhall Laboratories (060383791)

Revised: 11/2015 Golden Sun Inc DBA Newhall Laboratories

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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