ARNICA DE LA ABUELA- heterotheca inuloides cass, wintergreen, balsam of peru ointment 
LABORATORIOS BREMER, S.A.

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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

copy of label

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 AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HETEROTHECA INULOIDES FLOWER (UNII: W9NZ9OZF68) (HETEROTHECA INULOIDES FLOWER - UNII:W9NZ9OZF68) HETEROTHECA INULOIDES FLOWER0.59 g  in 104 mL
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE1.48 g  in 104 mL
BALSAM PERU (UNII: 8P5F881OCY) (BALSAM PERU - UNII:8P5F881OCY) BALSAM PERU0.88 g  in 104 mL
Inactive Ingredients
Ingredient NameStrength
PETROLATUM (UNII: 4T6H12BN9U)  
PARAFFIN (UNII: I9O0E3H2ZE)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:60854-001-0144 mL in 1 CAN; Type 0: Not a Combination Product01/01/2016
2NDC:60854-001-0231 mL in 1 CAN; Type 0: Not a Combination Product01/01/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01701/01/2016
Labeler - LABORATORIOS BREMER, S.A. (811585264)
Establishment
NameAddressID/FEIBusiness Operations
LABORATORIOS BREMER, S.A.811585264manufacture(60854-001)

Revised: 11/2023
Document Id: 0b5902e8-05ab-ed12-e063-6394a90a96c6
Set id: ee132c86-c8fc-4820-a081-3811344f9c11
Version: 3
Effective Time: 20231130
 
LABORATORIOS BREMER, S.A.