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.

----------

LaBella™ Linimento Obrero

Drug Facts

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

Use

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

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
LABELLA LINIMENTO OBRERO 
capsaicin, menthol, unspecified form, and methyl salicylate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:31774-8005
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Capsaicin (UNII: S07O44R1ZM) (Capsaicin - UNII:S07O44R1ZM) Capsaicin0.25 mg  in 1 mL
Menthol, Unspecified Form (UNII: L7T10EIP3A) (Menthol, Unspecified Form - UNII:L7T10EIP3A) Menthol, Unspecified Form20 mg  in 1 mL
Methyl Salicylate (UNII: LAV5U5022Y) (Salicylic Acid - UNII:O414PZ4LPZ) Methyl Salicylate100 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Stearic Acid (UNII: 4ELV7Z65AP)  
Isopropyl Palmitate (UNII: 8CRQ2TH63M)  
Propylene Glycol (UNII: 6DC9Q167V3)  
Cetyl Alcohol (UNII: 936JST6JCN)  
Glyceryl Monostearate (UNII: 230OU9XXE4)  
Stearyl Alcohol (UNII: 2KR89I4H1Y)  
Polysorbate 60 (UNII: CAL22UVI4M)  
Phenoxyethanol (UNII: HIE492ZZ3T)  
Methylparaben (UNII: A2I8C7HI9T)  
Propylparaben (UNII: Z8IX2SC1OH)  
Sorbitan Sesquioleate (UNII: 0W8RRI5W5A)  
Edetate Sodium (UNII: MP1J8420LU)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:31774-8005-1236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34601/02/2013
Labeler - Golden Sun Inc DBA Newhall Laboratories (060383791)

Revised: 11/2015
Document Id: 12bf2514-2813-46c3-a3b4-c3425cbeb162
Set id: fc5abe34-edf6-400a-bd28-1aea8bac8c70
Version: 1
Effective Time: 20151106
 
Golden Sun Inc DBA Newhall Laboratories