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ARNICA DE LA ABUELA

Dosage form: ointment
Ingredients: HETEROTHECA INULOIDES FLOWER .59g in 104mL, METHYL SALICYLATE 1.48g in 104mL, BALSAM PERU .88g in 104mL
Labeler: LABORATORIOS BREMER, S.A.
NDC Code: 60854-001

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

Gaultheria Procumbens (Wintergreen Oil) 0,05 Oz.

Myroxylon Pareirae (Balsam of Peru)  0,03 Oz

Helerotheca Inuloides Cass (Arnica Ext. Fluid)  0,02 Oz

Analgesic in the treatment of muscle pain

Dose and use way: Apply 2 or 3 times a day on the affected area

Contraindications: Hypersensitivity to the formula ingredients.

If the problem persist consult your doctor. Secondary reactions. In

case of skin irritations suspend this product use.

Warning:  Arnica (Extract) can be toxic if ingested

Wintergreen Oil can be toxic if ingested

For external use only

Pregnancy or nursing baby:  Yes, this product apply

on pregnancy and nursing women.

Caution: Keep out the reach of the children.

Indications: Analgesic in the treatment of muscle pain

Excipient (Petrolatum and Parafin) Q.S. 3.52 Oz

ARNICA DE LA ABUELA 
heterotheca inuloides cass, wintergreen, balsam of peru ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60854-001
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HETEROTHECA INULOIDES FLOWER (HETEROTHECA INULOIDES FLOWER) HETEROTHECA INULOIDES FLOWER.59 g  in 104 mL
METHYL SALICYLATE (SALICYLIC ACID) METHYL SALICYLATE1.48 g  in 104 mL
BALSAM PERU (BALSAM PERU) BALSAM PERU.88 g  in 104 mL
Inactive Ingredients
Ingredient NameStrength
PETROLATUM 
PARAFFIN 
Packaging
#Item CodePackage Description
1NDC:60854-001-0144 mL in 1 CAN
2NDC:60854-001-0231 mL in 1 CAN
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34801/01/2016
Labeler - LABORATORIOS BREMER, S.A. (811585264)
Establishment
NameAddressID/FEIOperations
LABORATORIOS BREMER, S.A.811585264manufacture(60854-001)

 
LABORATORIOS BREMER, S.A.

Medically reviewed on May 10, 2018

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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