ABEJAS Y VIBORAS BRAND ROLL-ON- menthol gel

Abejas y Viboras Brand Roll-On by

Drug Labeling and Warnings

Abejas y Viboras Brand Roll-On by is a Otc medication manufactured, distributed, or labeled by MENPER DISTRIBUTORS INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient

Menthol 5%

PURPOSE

Purpose

Topical Analgesic

INDICATIONS & USAGE

Uses

• for the temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthristis, strains and sprains.

WARNINGS

Warnings

For external use only

Do not use

• on wounds or damaged skin
• with a heating pad
• on a child 12 years of age and under
• over extensive 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 persists for more than 7 days
• symptoms clear up and occur again within a few days
• excessive skin irritation occurs

PREGNANCY OR BREAST FEEDING

If pregnant or breast-feeding, ask a health profiessional before use.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children to avoid accidental poisoning. If swallowed, induce vomiting and call a physician or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION

Directions

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

INACTIVE INGREDIENT

Inactive ingredients Camphor, carbomer 940, D&C yellow #10, FD&C yellow #5, glycerin, isopropyl myristate, methyl salicylate, methylchloroisothiazolinone, methlylisothiazolinone, polysorbate 20, propylene glycol, triethanolamine, water.

QUESTIONS

Questions? Call 1-800-560-5223 M-F 9 AM to 4 PM Eastern

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ABEJAS Y VIBORAS BRAND ROLL-ON 
menthol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53145-703
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	5 mg  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)
CARBOMER 940 (UNII: 4Q93RCW27E)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
GLYCERIN (UNII: PDC6A3C0OX)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
METHYL SALICYLATE (UNII: LAV5U5022Y)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
TROLAMINE (UNII: 9O3K93S3TK)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53145-703-03	1 in 1 CARTON	03/01/2021
1		88 mL in 1 BOTTLE; 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	03/01/2021

Labeler - MENPER DISTRIBUTORS INC. (101947166)