Cold Zone Pain Relieving Gel- Rite Aid

Cold Zone Pain Relieving Gel- Rite Aid
SPL v3
SPL
SPL Set ID 17d58555-6089-4ebe-bbb5-cc77b5ac1d0d
Route
TOPICAL
Published
Effective Date 2018-07-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (40 mg)
Inactive Ingredients
Camphor (natural) Brilliant Blue G Petrolatum Carboxypolymethylene Aloe Vera Leaf Arnica Montana Flower Arctium Lappa Whole Calendula Officinalis Flower Frankincense Green Tea Leaf Ilex Paraguariensis Leaf Melissa Officinalis Leaf Isopropyl Alcohol Isopropyl Myristate .alpha.-tocopherol Acetate Silicon Dioxide Trolamine Sorbic Acid Water Fd&c Blue No. 1 Fd&c Yellow No. 5

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2018-01-22

Description

Menthol USP 4%

Purpose

Cooling Pain Relief


Medication Information

Purpose

Cooling Pain Relief

Description

Menthol USP 4%

Uses

Temporary relief from minor aches and pains of sore muscles and joints associated with: - arthritis - backache - strains - sprains

Warnings:

For external use only

Flammable:

Keep away from excessive heat or open flame.

Directions:



  • Adults and children 2 years of age and older: Rub a thin film over affected areas not more than 4 times daily; massage not necessary
  • Children under 2 years of age: Consult physician

Active Ingredients



Menthol USP 4%

Other Information:

Store in a cool dry place with lid closed tightly.

Questions or Comments - Call 1-855-314-1850

Inactive Ingredients

Purified water, Glycerin, Isopropyl alcohol, Iso propyl myristate, Carbopol usp, Aloevera gel, Arnica montana flower extract, Articum lappa root (burdock) extract, Boswellia carterii resin extract, Calendula officinalis extract, Camellia sinensis leaf extract, camphorm934, colloidal silicon dioxide, FD&C blue no. 1, FD&C yellow no. 5, glycerin,  Iiex paraguariensis leaf extract, Isopropyl alchohol, Isopropyl myristate, Melissa officinalis (lemon balm) leaf extract, Tocopheryl acetate, Triethanolamine, Sorbic acid.

When Using This Product:



  • Avoid contact with the eyes or mucous membranes
  • Do not apply to wounds or damaged skin
  • Do not use with other ointments, creams, sprays or liniments

  • Do not apply to irritated skin or if excessive irritated develops

  • Do not bandage

  • Wash hands after use with cool water
  • Do not use with heating pad or device

Stop Use and Ask A Doctor If:

Condition worsens, or if symptoms  persist for more than 7 days, or clear up and recur

If Pregnant Or Breast Feeding:

Ask a health professional before use

Keep Out of Reach of Children:

If accidentally ingested, get medical help or contact a Poison Control Center immediately

Ask A Doctor Before Use If You Have:

sensitive skin

Cold Zone Pain Relieving Gel Rite Aid


Structured Label Content

Uses

Temporary relief from minor aches and pains of sore muscles and joints associated with: - arthritis - backache - strains - sprains

Purpose

Cooling Pain Relief

Warnings:

For external use only

Flammable:

Keep away from excessive heat or open flame.

Directions:



  • Adults and children 2 years of age and older: Rub a thin film over affected areas not more than 4 times daily; massage not necessary
  • Children under 2 years of age: Consult physician

Active Ingredients



Menthol USP 4%

Other Information:

Store in a cool dry place with lid closed tightly.

Questions or Comments - Call 1-855-314-1850

Inactive Ingredients

Purified water, Glycerin, Isopropyl alcohol, Iso propyl myristate, Carbopol usp, Aloevera gel, Arnica montana flower extract, Articum lappa root (burdock) extract, Boswellia carterii resin extract, Calendula officinalis extract, Camellia sinensis leaf extract, camphorm934, colloidal silicon dioxide, FD&C blue no. 1, FD&C yellow no. 5, glycerin,  Iiex paraguariensis leaf extract, Isopropyl alchohol, Isopropyl myristate, Melissa officinalis (lemon balm) leaf extract, Tocopheryl acetate, Triethanolamine, Sorbic acid.

When Using This Product: (When using this product:)



  • Avoid contact with the eyes or mucous membranes
  • Do not apply to wounds or damaged skin
  • Do not use with other ointments, creams, sprays or liniments

  • Do not apply to irritated skin or if excessive irritated develops

  • Do not bandage

  • Wash hands after use with cool water
  • Do not use with heating pad or device

Stop Use and Ask A Doctor If: (Stop use and ask a doctor if:)

Condition worsens, or if symptoms  persist for more than 7 days, or clear up and recur

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 accidentally ingested, get medical help or contact a Poison Control Center immediately

Ask A Doctor Before Use If You Have: (Ask a doctor before use if you have:)

sensitive skin

Cold Zone Pain Relieving Gel Rite Aid (Cold Zone Pain Relieving Gel- Rite Aid)


Advanced Ingredient Data


Raw Label Data

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