ARNICA DE LA ABUELA- heterotheca inuloides cass, wintergreen, balsam of peru ointment

ARNICA DE LA ABUELA by

Drug Labeling and Warnings

ARNICA DE LA ABUELA by is a Otc medication manufactured, distributed, or labeled by LABORATORIOS BREMER, S.A.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Gaultheria Procumbens (Wintergreen Oil) 0,05 Oz.

Myroxylon Pareirae (Balsam of Peru)  0,03 Oz

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

PURPOSE

Analgesic in the treatment of muscle pain

DOSAGE & ADMINISTRATION

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

WARNINGS

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 BREAST FEEDING

Pregnancy or nursing baby:  Yes, this product apply

on pregnancy and nursing women.

KEEP OUT OF REACH OF CHILDREN

Caution: Keep out the reach of the children.

INDICATIONS & USAGE

Indications: Analgesic in the treatment of muscle pain

INACTIVE INGREDIENT

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ARNICA DE LA ABUELA 
heterotheca inuloides cass, wintergreen, balsam of peru ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 60854-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HETEROTHECA INULOIDES FLOWER (UNII: W9NZ9OZF68) (HETEROTHECA INULOIDES FLOWER - UNII:W9NZ9OZF68)	HETEROTHECA INULOIDES FLOWER	.59 g  in 104 mL
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	METHYL SALICYLATE	1.48 g  in 104 mL
BALSAM PERU (UNII: 8P5F881OCY) (BALSAM PERU - UNII:8P5F881OCY)	BALSAM PERU	.88 g  in 104 mL

Inactive Ingredients
Ingredient Name	Strength
PETROLATUM (UNII: 4T6H12BN9U)
PARAFFIN (UNII: I9O0E3H2ZE)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 60854-001-01	44 mL in 1 CAN; Type 0: Not a Combination Product	01/01/2016
2	NDC: 60854-001-02	31 mL in 1 CAN; Type 0: Not a Combination Product	01/01/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	01/01/2016

Labeler - LABORATORIOS BREMER, S.A. (811585264)

Establishment
Name	Address	ID/FEI	Business Operations
LABORATORIOS BREMER, S.A.		811585264	manufacture(60854-001)