Abejas Y Vivoras Roll On

Abejas Y Vivoras Roll On
SPL v3
SPL
SPL Set ID bedf3b36-7def-099f-e053-2a95a90ac15b
Route
TOPICAL
Published
Effective Date 2021-03-31
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (10 g)
Inactive Ingredients
Water Polysorbate 20 Arnica Montana Flower Camphor Oil Propylene Glycol Polyacrylic Acid (250000 Mw) Dmdm Hydantoin Eucalyptus Oil Capsicum Trolamine Menthol Isopropyl Alcohol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-03-31

Description

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


Medication Information

Description

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
Section 55105-1
Active ingredient Purpose
Methyl salicylate 10% .................... Topical analgesic

Warnings

For external use only.

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
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
Questions?

1-800-560-5223M-F 9AM – 4 PM Eastern

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

Principal Display Panel

Abejas y Viboras

External Analgesic Cream

Methyl Salicylate 10%

ROLL-ON

Pain Relieving Luquid

3 fl oz (88mL)

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.

Ask A Doctor Before Use If You Have
  • redness over the affected area
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.


Structured Label Content

Uses

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

  • simple backache
  • arthritis
  • strains
  • sprains
Section 55105-1 (55105-1)
Active ingredient Purpose
Methyl salicylate 10% .................... Topical analgesic

Warnings

For external use only.

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
Do Not Use (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
Questions?

1-800-560-5223M-F 9AM – 4 PM Eastern

Other Information (Other information)
  • store at 15°–25°C(59°– 77°F)
Inactive Ingredients (Inactive ingredients)

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

Principal Display Panel

Abejas y Viboras

External Analgesic Cream

Methyl Salicylate 10%

ROLL-ON

Pain Relieving Luquid

3 fl oz (88mL)

When Using This Product (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 (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, (If pregnant or breast-feeding,)

ask a health professional before use.

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • redness over the affected area
Keep Out of Reach of Children to Avoid Accidental Poisoning. (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.


Advanced Ingredient Data


Raw Label Data

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