Rite Aid Hot & Cold Roll-on

Rite Aid Hot & Cold Roll-on
SPL v2
SPL
SPL Set ID fc4b2635-280b-267f-e053-6294a90a5e22
Route
TOPICAL
Published
Effective Date 2023-05-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (16 g)
Inactive Ingredients
Phenoxyethanol Carbomer Interpolymer Type B (allyl Pentaerythritol Crosslinked) Glycerin Water Alcohol Propylene Glycol Xanthan Gum

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-05-22

Description

Menthol 16%


Medication Information

Warnings and Precautions

Flammable--keep away from fire or flame.

For external use only.

When using this product keep out of 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 and occur again within a few days, and redness or irritation develops.

Indications and Usage

For the temporary relief of minor pain associated with arthritis, simple backache, muscle strains, sprains, bruises, and cramps.

Dosage and Administration

Clean affected area before applying product • adults and children 12 years and older, apply to affected area not more

than 3 to 4 times daily. • Children under 12 years old, ask a doctor

Description

Menthol 16%

Section 50565-1

If product is swallowed, get medical help or contact a Poison Control Center right away.

Section 51727-6

Acrylates/C10-30 alkyl acrylate crosspolymer, alcohol denat., glycerin, phenoxyethanol, propylene glycol, water, xanthan gum

Section 51945-4

Section 55105-1

External Analgesic

Section 55106-9

Menthol 16%


Structured Label Content

Indications and Usage (34067-9)

For the temporary relief of minor pain associated with arthritis, simple backache, muscle strains, sprains, bruises, and cramps.

Dosage and Administration (34068-7)

Clean affected area before applying product • adults and children 12 years and older, apply to affected area not more

than 3 to 4 times daily. • Children under 12 years old, ask a doctor

Warnings and Precautions (34071-1)

Flammable--keep away from fire or flame.

For external use only.

When using this product keep out of 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 and occur again within a few days, and redness or irritation develops.

Section 50565-1 (50565-1)

If product is swallowed, get medical help or contact a Poison Control Center right away.

Section 51727-6 (51727-6)

Acrylates/C10-30 alkyl acrylate crosspolymer, alcohol denat., glycerin, phenoxyethanol, propylene glycol, water, xanthan gum

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

External Analgesic

Section 55106-9 (55106-9)

Menthol 16%


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)