Rite Aid Roll-on

Rite Aid Roll-on
SPL v3
SPL
SPL Set ID b777b759-3cc9-4a99-aec6-5579945b8d21
Route
TOPICAL
Published
Effective Date 2018-07-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (40 mg)
Inactive Ingredients
Silicon Dioxide .alpha.-tocopherol Acetate Trolamine Water Fd&c Blue No. 1 Fd&c Yellow No. 5 Aloe Vera Leaf Arnica Montana Flower Frankincense Calendula Officinalis Flower Green Tea Leaf Glycerin Ilex Paraguariensis Leaf Isopropyl Alcohol Isopropyl Myristate Melissa Officinalis Leaf

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2018-07-17

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

Section 51945-4

Warnings:

For external use only

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

Drug Facts



Flammable:

Keep away from excessive heat or open flame

Active Ingredients

Menthol USP 4%

Other Information:

Store in a cool dry place with lid closed tightly

Inactive Ingredients:

Aloe Vera gel, Camphor, Carbomer, FD&C blue 1, FD&C yellow 5 Glycerol, Isopropyl Alcohol, Ispropyl Myristate, Purified water, Silica, triethanolamine, Tocopheryl (Vitamin E) Acetate, 

Questions Or Comments

1-855-314-1850

When Using This Product:
  • Avoid contact with 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 skin irritation 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 reoccur

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


Structured Label Content

Uses:

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

Section 51945-4 (51945-4)

Purpose

Cooling Pain Relief

Warnings:

For external use only

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

Drug Facts



Flammable:

Keep away from excessive heat or open flame

Active Ingredients

Menthol USP 4%

Other Information:

Store in a cool dry place with lid closed tightly

Inactive Ingredients:

Aloe Vera gel, Camphor, Carbomer, FD&C blue 1, FD&C yellow 5 Glycerol, Isopropyl Alcohol, Ispropyl Myristate, Purified water, Silica, triethanolamine, Tocopheryl (Vitamin E) Acetate, 

Questions Or Comments (Questions or Comments)

1-855-314-1850

When Using This Product: (When using this product:)
  • Avoid contact with 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 skin irritation 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 reoccur

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


Advanced Ingredient Data


Raw Label Data

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