e626d2cc-caf8-4515-9959-d2def58c7be3

SPL v1
SPL
SPL Set ID e626d2cc-caf8-4515-9959-d2def58c7be3
Route
topical
Published
Effective Date 2010-09-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
menthol (.07 g)
Inactive Ingredients
water alcohol trolamine carbomer interpolymer type a (55000 cps) benzocaine laureth-4 thymol english lavender oil aloe dimethyl sulfone camphor (synthetic) peppermint oil eucalyptus oil magnesium sulfate, unspecified rosemary oil patchouli oil ginger oil sage oil oregano glucosamine chondroitin sulfate (bovine) lithium chloride potassium chloride cupric sulfate anhydrous ammonium chloride calcium sulfate calcium carbonate arnica montana elm stellaria media comfrey myrrh hops plantago major green tea leaf althaea officinalis root fd&c blue no. 1

Identifiers & Packaging

Marketing Status
otc monograph not final active Since 2004-08-24
Description

Active Ingredient Menthol 7%

Medication Information

Warnings and Precautions




  • For external use only
Active Ingredient
Active Ingredient



Menthol 7%
Indications and Usage
Uses



For the temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises and sprains.

Dosage and Administration


Directions
  • Adults and children 2 years and over: Clean skin of all other ointments, creams, sprays or liniments.  Apply directly to affected areas no more than 3 to 4 times daily.  Wash hands after application to help avoid contact with eyes and sensitive areas. May be used with wet or dry bandages or with ice packs.
  • Children under 2 years of age:  ask a doctor
Description

Active Ingredient Menthol 7%

Section 50565-1
Keep out of reach of children.  If swallowed, get medical help or contact a Poison Control Center right away.
Section 50566-9

Stop use and ask a doctor if:

  • a rash appears
  • condition worsens or if symptoms persist for more than 7 days, or clear up and occur again within a few days

Section 50567-7

When using this product

  • avoid contact with eyes

Section 50570-1
Do not use



  •  on wounds or damaged skin
  • with heating pads or heating devices
  •  with other ointments, creams, sprays or liniments
  •  with tight bandages
Section 51727-6
Inactive Ingredients   Water, Alcohol, Laureth-4, Carbomer, Triethanolamine, Aloe Vera, Benzocaine, Thymol, Camphor, Methylsulfonylmethane (MSM), Glucosamine HCl, Chondroitin Sulfate, Oil Complex - (Oregano, Eucalyptus, Sage, Patchouli, Lavender, Rosemary, Ginger, Peppermint), Fragrance, Mineral Complex - (Magnesium Sulfate, Copper Sulfate, Calcium Sulfate, Calcium Carbonate, Lithium Chloride, Potassium Chloride, Sodium Sesquicarbonate, Ammonium Chloride), Herbal Complex - (Arnica, Slippery Elm, Chickweed, Comfrey, Myrrh, Hops, Marshmallow, Plantain, Green Tea), FD and C Blue No. 1.
Section 51945-4
ID:                        Med1

Descriptive Text:   Medic Ice label

File Name:            medicice.jpg







Section 53414-9

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

Section 55105-1
Purpose



Pain relieving gel

Structured Label Content

Warnings and Precautions (34071-1)




  • For external use only
Active Ingredient (55106-9)
Active Ingredient



Menthol 7%
Indications and Usage (34067-9)
Uses



For the temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises and sprains.

Dosage and Administration (34068-7)


Directions
  • Adults and children 2 years and over: Clean skin of all other ointments, creams, sprays or liniments.  Apply directly to affected areas no more than 3 to 4 times daily.  Wash hands after application to help avoid contact with eyes and sensitive areas. May be used with wet or dry bandages or with ice packs.
  • Children under 2 years of age:  ask a doctor
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 50566-9 (50566-9)

Stop use and ask a doctor if:

  • a rash appears
  • condition worsens or if symptoms persist for more than 7 days, or clear up and occur again within a few days

Section 50567-7 (50567-7)

When using this product

  • avoid contact with eyes

Section 50570-1 (50570-1)
Do not use



  •  on wounds or damaged skin
  • with heating pads or heating devices
  •  with other ointments, creams, sprays or liniments
  •  with tight bandages
Section 51727-6 (51727-6)
Inactive Ingredients   Water, Alcohol, Laureth-4, Carbomer, Triethanolamine, Aloe Vera, Benzocaine, Thymol, Camphor, Methylsulfonylmethane (MSM), Glucosamine HCl, Chondroitin Sulfate, Oil Complex - (Oregano, Eucalyptus, Sage, Patchouli, Lavender, Rosemary, Ginger, Peppermint), Fragrance, Mineral Complex - (Magnesium Sulfate, Copper Sulfate, Calcium Sulfate, Calcium Carbonate, Lithium Chloride, Potassium Chloride, Sodium Sesquicarbonate, Ammonium Chloride), Herbal Complex - (Arnica, Slippery Elm, Chickweed, Comfrey, Myrrh, Hops, Marshmallow, Plantain, Green Tea), FD and C Blue No. 1.
Section 51945-4 (51945-4)
ID:                        Med1

Descriptive Text:   Medic Ice label

File Name:            medicice.jpg







Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)
Purpose



Pain relieving gel

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:55:08.573685 · Updated: 2026-03-14T22:52:29.225907