Amar

Amar
SPL v3
SPL
SPL Set ID 1ca34e8a-959d-4e48-b89a-e42ca0df46aa
Route
TOPICAL
Published
Effective Date 2011-04-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (2.5 g)
Inactive Ingredients
Camphor (synthetic) Methylparaben Sodium Propylparaben Sodium Methyl Salicylate Propylene Glycol Phenoxyethanol Propyl Alcohol Water

Identifiers & Packaging

Pill Appearance
Color: blue
Marketing Status
OTC MONOGRAPH FINAL Active Since 2010-05-01

Description

Drug Facts

Purpose

Topical analgesic


Medication Information

Purpose

Topical analgesic

Description

Drug Facts

Uses
  • temporarily relieves minor aches and pains of muscles and joints associated with:
    • arthritis
    • bruises
    • simple backache
    • sport injuries
    • strains
    • sprains
  • provides cooling penetrating relief
Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 53414-9

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

Warnings

For external use only

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
Do Not Use
  • with heating pads or heating devices
Active Ingredient

Menthol 2.5%

Other Information
  • store in a cool place
  • keep lid tightly closed
  • do not use, pour, spill or store near heat or open flame
Inactive Ingredients

Water, Camphor, Carbopol, Methyl Paraben Sodium, Propyl Paraben Sodium, Wintergreen oil, Propylene Glycol, Phenoxy ethanol, ISO Propyl alcohol, Sodium Hydroxide, Cl 42090.

When Using This Product
  • do not use in or near the eyes
  • 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
Principal Display Panel 227 G Jar Label

Amar

ICE GEL

Net Wt 8 oz (227g)


Structured Label Content

Uses
  • temporarily relieves minor aches and pains of muscles and joints associated with:
    • arthritis
    • bruises
    • simple backache
    • sport injuries
    • strains
    • sprains
  • provides cooling penetrating relief
Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 53414-9 (53414-9)

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

Purpose

Topical analgesic

Warnings

For external use only

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
Do Not Use (Do not use)
  • with heating pads or heating devices
Active Ingredient

Menthol 2.5%

Other Information (Other information)
  • store in a cool place
  • keep lid tightly closed
  • do not use, pour, spill or store near heat or open flame
Inactive Ingredients (Inactive ingredients)

Water, Camphor, Carbopol, Methyl Paraben Sodium, Propyl Paraben Sodium, Wintergreen oil, Propylene Glycol, Phenoxy ethanol, ISO Propyl alcohol, Sodium Hydroxide, Cl 42090.

When Using This Product (When using this product)
  • do not use in or near the eyes
  • 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
Principal Display Panel 227 G Jar Label (PRINCIPAL DISPLAY PANEL - 227 g Jar Label)

Amar

ICE GEL

Net Wt 8 oz (227g)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)