96854a49-a5b9-40c4-9e4f-a8ad07cfed08

SPL v1
SPL
SPL Set ID 96854a49-a5b9-40c4-9e4f-a8ad07cfed08
Route
topical
Published
Effective Date 2012-10-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
menthol (.02 g)
Inactive Ingredients
ammonia cupric sulfate fd&c blue no. 1 isopropyl alcohol magnesium sulfate sodium hydroxide thymol water

Identifiers & Packaging

Marketing Status
otc monograph not final active Since 2012-10-02

Purpose

Topical analgesic

Description

Menthol


Medication Information

Warnings

For external use only

Uses

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

● arthritis ● simple backache ● strains

● bruises ● sprains

Purpose

Topical analgesic

Directions
  • clean affected area before applying product
  • adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily
  • children under 2 years of age: ask a doctor
Other Information
  • store at room temperature
  • keep lid tightly closed
  • do not use, pour, spill or store near heat or open flame
Inactive Ingredients

ammonium hydroxide, carbomer, cupric sulfate, FD&C blue no. 1, isopropyl alcohol, magnesium sulfate, sodium hydroxide, thymol, water

Description

Menthol

Do Not Use
  • with other topical pain relievers
  • with heating pads or heating devices
Package Label

Vida Mia Blue Ice Gel

Active Ingredient

Menthol

When Using This Product
  • avoid contact with the eyes
  • use only as directed
  • do not apply to wounds or damaged skin
  • do not bandage tightly
Stop Use and Ask A Doctor If
  • condition worsens
  • symptoms last more than 7 days or clear up and occur again within a few days
  • redness or irritation develops
If Pregnant Or Breast Feeding,

ask a health professional before use

Keep Out of Reach of Children.

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


Structured Label Content

Warnings

For external use only

Uses

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

● arthritis ● simple backache ● strains

● bruises ● sprains

Purpose

Topical analgesic

Directions
  • clean affected area before applying product
  • adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily
  • children under 2 years of age: ask a doctor
Other Information (Other information)
  • store at room temperature
  • keep lid tightly closed
  • do not use, pour, spill or store near heat or open flame
Inactive Ingredients (Inactive ingredients)

ammonium hydroxide, carbomer, cupric sulfate, FD&C blue no. 1, isopropyl alcohol, magnesium sulfate, sodium hydroxide, thymol, water

Do Not Use (Do not use)
  • with other topical pain relievers
  • with heating pads or heating devices
Package Label (Package label)

Vida Mia Blue Ice Gel

Active Ingredient

Menthol

When Using This Product (When using this product)
  • avoid contact with the eyes
  • use only as directed
  • do not apply to wounds or damaged skin
  • do not bandage tightly
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • condition worsens
  • symptoms last more than 7 days or clear up and occur again within a few days
  • redness or irritation develops
If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use

Keep Out of Reach of Children. (Keep out of reach of children.)

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


Advanced Ingredient Data


Raw Label Data

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