OTC Medication Information: Mobility

MOBILITY- methyl salicylate, menthol, camphor oil and capsicum oleoresin oil
Mayway Corporation

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.

Active ingredients

Active ingredients Purpose
Methyl Salicylate 20%…………………………………………..External Analgesic
Menthol 8%…………………………………………………………External Analgesic
Camphor 4% ………………………………………………………External Analgesic
Capsicum Oleoresin 0.25%……………………………………External Analgesic

• condition worsens
• symptoms persist for more than 7 days
• symptoms clear up and occur again within a few days
• excessive irritation of the skin develops
• nausea, vomiting, abdominal discomfort, or diarrhea occurs
• pain persists for more than 10 days
• redness is present
• in conditions affecting children under 12 years of ageDo not use otherwise than as directed

Keep out of reach of children

Keep out of reach of children to avoid accidental poisoning.

If swallowed, get medical help or contact a Poison Control Center right away

Do not use otherwise than as directed

Directions

Pregnant or breastfeeding women and children under 12: Do not use or consult a doctor

Directions

• adults and children 12 years of age and older: Apply generously to the affected area and massage until thoroughly absorbed into skin

• repeat as necessary but not more than 4 times daily.

• pregnant or breastfeeding women and children under 3: Do not use or consult a doctor

Other information

• Keep tightly closed
• Store at room temperature, 20° to 25°C(68° to 77F)

Inactive ingredients

Frankincense oil, Ligusticum chuanxiong rhizome oil, Mineral Oil, Myrrh oil, Peppermint oil, Pine oil, Terpineol, Thyme oil, Turpentine oil

Questions?

+1-800-262-9929 M-F 9am — 5pm

Warnings

For external use only

Purpose

Active ingredients Purpose
Methyl Salicylate 20%…………………………………………..External Analgesic
Menthol 8%…………………………………………………………External Analgesic
Camphor 4% ………………………………………………………External Analgesic
Capsicum Oleoresin 0.25%……………………………………External Analgesic

Do not use

• on wounds
• irritated or damaged skin
• if allergic to aspirin or other NSAIDs

When using this product

• avoid contact with the eyes or mucous membranes
• do not bandage tightly or use with heating pad
• do not apply to wounds or damaged skin

Stop use and ask a doctor if

• condition worsens
• symptoms persist for more than 7 days
• symptoms clear up and occur again within a few days
• excessive irritation of the skin develops
• nausea, vomiting, abdominal discomfort, or diarrhea occurs
• pain persists for more than 10 days
• redness is present
• in conditions affecting children under 12 years of age

Warnings

For external use only

Uses

For the temporary relief of minor aches and pains of muscles and joints due to:

• arthritis
• strains
• bruises
• sprains
• simple backache

Mobility Principal Display Panel

Mobility Principal Display Panel

MOBILITY methyl salicylate oil

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:33346-3401 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength METHYL SALICYLATE (SALICYLIC ACID) METHYL SALICYLATE 10 g in 50 mL MENTHOL (MENTHOL) MENTHOL 4 g in 50 mL CAMPHOR OIL (CAMPHOR OIL) CAMPHOR OIL 2 g in 50 mL CAPSICUM OLEORESIN (CAPSICUM OLEORESIN) CAPSAICIN 0.125 g in 50 mL

Inactive Ingredients Ingredient Name Strength TURPENTINE OIL LIGUSTICUM SINENSE SUBSP. CHUANXIONG WHOLE FRANKINCENSE OIL MYRRH OIL MINERAL OIL PEPPERMINT OIL PINE NEEDLE OIL (PINUS SYLVESTRIS) TERPINEOL THYME OIL

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:33346-3401-2 1 VIAL, GLASS in 1 BOX contains a VIAL, GLASS (33346-3401-1) 1 NDC:33346-3401-1 50 mL in 1 VIAL, GLASS This package is contained within the BOX (33346-3401-2)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 10/26/2018

Labeler — Mayway Corporation (093077618)

Revised: 01/2021 Mayway Corporation