LABELLA LINIMENTO OBRERO- capsaicin, menthol, unspecified form, and methyl salicylate cream

LaBella Linimento Obrero by

Drug Labeling and Warnings

LaBella Linimento Obrero by is a Otc medication manufactured, distributed, or labeled by Golden Sun Inc DBA Newhall Laboratories. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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Drug Facts

ACTIVE INGREDIENT

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

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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)

INGREDIENTS AND APPEARANCE

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Capsaicin (UNII: S07O44R1ZM) (Capsaicin - UNII:S07O44R1ZM)	Capsaicin	0.25 mg  in 1 mL
Menthol, Unspecified Form (UNII: L7T10EIP3A) (Menthol, Unspecified Form - UNII:L7T10EIP3A)	Menthol, Unspecified Form	20 mg  in 1 mL
Methyl Salicylate (UNII: LAV5U5022Y) (Salicylic Acid - UNII:O414PZ4LPZ)	Methyl Salicylate	100 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 31774-8005-1	236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

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)