Abejas y Viboras Roll On by Menper Distributors Inc. Abejas y Vivoras Roll On

Abejas y Viboras Roll On by

Drug Labeling and Warnings

Abejas y Viboras Roll On by is a Otc medication manufactured, distributed, or labeled by Menper Distributors Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ABEJAS Y VIBORAS ROLL ON- methyl salicylate liquid 
Menper Distributors Inc.

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.

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Abejas y Vivoras Roll On

Drug Facts

Active ingredient and Purpose

• Active ingredient: Purpose
• Methyl salicylate 10% ....................: Topical analgesic

Uses

For the temporary relief of minor aches and pains of muscles and joints associated with

• simple backache
• arthritis
• strains
• sprains

Warnings

For external use only.

Do not use

• on wounds or damaged skin
• with a heating pad
• on a child 12 years o age and under
• over estensive areas of the body
• on irritated skin
• with a bandage
• with other ointments, creams, sprays or liniments

Ask a doctor before use if you have

• redness over the affected area

When using this product

• wash hands after use with cool water
• avoid contact with eyes or mucous membranes
• do not bandage

Stop use and ask a doctor if

• condition worsens or symptoms persist for more than 7 days
• symptoms clear up and and occur again within a few days
• excessive skin irritation occurs

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children to avoid accidental poisoning.

If swallowed, induce vomiting and call a physicaian or contact a Poision Control Center right away.

Directions

• use only as directed
• adults and children over 12 years: rub a thin film over affected areas not more than 4 times daily
• children 12 years or younger: do not use

Other information

• store at 15°–25°C(59°– 77°F)

Inactive ingredients

arnica oil, camphor, capsicum extract, carbomer, dmdm hydantoin, eucalyptus oil, isopropyl alcohol, menthol, polysorbate 20, propylene glycol, triethanolamine, water

Questions?

1-800-560-5223 M-F 9AM – 4 PM Eastern

Principal Display Panel

Abejas y Viboras

External Analgesic Cream

Methyl Salicylate 10%

ROLL-ON

Pain Relieving Luquid

3 fl oz (88mL)

ABEJAS Y VIBORAS ROLL ON 
methyl salicylate liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53145-705
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	METHYL SALICYLATE	10 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
CAMPHOR OIL (UNII: 75IZZ8Y727)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
POLYACRYLIC ACID (250000 MW) (UNII: 9G2MAD7J6W)
DMDM HYDANTOIN (UNII: BYR0546TOW)
EUCALYPTUS OIL (UNII: 2R04ONI662)
CAPSICUM (UNII: 00UK7646FG)
TROLAMINE (UNII: 9O3K93S3TK)
MENTHOL (UNII: L7T10EIP3A)
ISOPROPYL ALCOHOL (UNII: ND2M416302)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53145-705-03	1 in 1 BOX	03/31/2021
1		88 g in 1 BOTTLE, WITH APPLICATOR; 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	part348	03/31/2021

Labeler - Menper Distributors Inc. (101947166)

Revised: 3/2021

Document Id: bedf3b36-7df0-099f-e053-2a95a90ac15b

34390-5

Set id: bedf3b36-7def-099f-e053-2a95a90ac15b

Version: 1

Effective Time: 20210331