Ralli Rapid Pain Relief Roll On

Ralli Rapid Pain Relief Roll On
SPL v1
SPL
SPL Set ID 978d5c2c-fdc4-4d25-83ec-0b9404ec8018
Route
TOPICAL
Published
Effective Date 2024-02-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (100 mg)
Inactive Ingredients
Indian Frankincense Carbomer Homopolymer, Unspecified Type Dimethyl Sulfone Eucalyptus Oil Glucosamine Sulfate Glycerin Peg-8 Dimethicone (600 Cst) Pentylene Glycol Peppermint Oil Trolamine Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-02-01

Description

Menthol 10.0%

Purpose

Topical Analgesic


Medication Information

Purpose

Topical Analgesic

Description

Menthol 10.0%

Uses

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

Warnings

For external use only. Avoid contact with eyes.

Flammable: Keep away from fire or flame.

Directions

Adults and children 2 years of age and older: • roll directly onto affected area without the need to rub, massage or bandage • repeat if necessary, but do not apply more than 3 to 4 times daily.

Children under 2 years of age: do not use, consult a doctorr.

Drug Facts

Active Ingredient

Menthol 10.0%

Other Information

• Store at room temperature

Package Labeling:

Inactive Ingredients

boswellia serrata extract, Carbomer, dimethylsulfone (MSM), eucalyptus oil, glucosamine sulfate, glycerin, PEG-8 dimethicone, pentylene glycol, peppermint oil, SD alcohol 39C, triethanolamine, water (USP).

When Using This Product

• use only as directed • do not bandage tightly or use a heating pad • do not apply to wounds or damaged skin

Stop Use and Ask A Doctor If

• condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days • redness is present • excessive irritation of the skin 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

Uses

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

Purpose

Topical Analgesic

Warnings

For external use only. Avoid contact with eyes.

Flammable: Keep away from fire or flame.

Directions

Adults and children 2 years of age and older: • roll directly onto affected area without the need to rub, massage or bandage • repeat if necessary, but do not apply more than 3 to 4 times daily.

Children under 2 years of age: do not use, consult a doctorr.

Drug Facts

Active Ingredient

Menthol 10.0%

Other Information

• Store at room temperature

Package Labeling:

Inactive Ingredients

boswellia serrata extract, Carbomer, dimethylsulfone (MSM), eucalyptus oil, glucosamine sulfate, glycerin, PEG-8 dimethicone, pentylene glycol, peppermint oil, SD alcohol 39C, triethanolamine, water (USP).

When Using This Product (When using this product)

• use only as directed • do not bandage tightly or use a heating pad • do not apply to wounds or damaged skin

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 occur again within a few days • redness is present • excessive irritation of the skin 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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