Astonea Cold Therapy 4% Menthol

Astonea Cold Therapy 4% Menthol
SPL v1
SPL
SPL Set ID 137cec16-20e9-ab5c-e063-6294a90a11db
Route
TOPICAL
Published
Effective Date 2024-03-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (4 g)
Inactive Ingredients
Polyethylene Glycol 2000 Glycerin Dmdm Hydantoin Edetate Sodium Carbomer 940 Isopropyl Alcohol Fd&c Yellow No. 5 Fd&c Blue No. 1 Hydrogenated Castor Oil Sodium Hydroxide Water Camphor (synthetic)

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-03-12

Description

Menthol 4%


Medication Information

Warnings and Precautions

For external use only

Flammable:Keep away from excessive heat or open flame

Indications and Usage

Temporary relief from minor aches and pains of sore muscles and joints associated with:

arthritis

backache

strains

sprains

Dosage and Administration

Directions

Adults and children 2 years of age and older:Rub a thin film over affected areas not more than daily: massage not necessary

Children under 2 years of age :Consult physician

Description

Menthol 4%

Section 50565-1

Keep out of reach of children: If accidentally ingested, get medical help or contact a poison Control immediately (1800-222-1222)

Section 50567-7

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 irritation develops ■do not bandage ■ wash hands alter use with cool water ■do not use with heating pad or device

Section 50569-3

Ask a doctor before use if you have: sensitive skin

Stop use and ask a doctor if

condition worsens or symptoms persist for more than 7 days or clear up and occur again within a few days.

Section 51727-6

camphor, carbopol 940, DMDM hydantoin, edetate disodium, FD&C yellow no. 5, FD&C blue no. 1, isopropyl alcohol, PEG 40

hydrogenated castor oil, propylene glycol, sodium hydroxide, water

Section 51945-4

Section 53414-9

If pregnant or breastfeeding, ask a health professional before use

Section 55105-1

Topical Analgesic

Section 55106-9

Menthol 4%


Structured Label Content

Indications and Usage (34067-9)

Temporary relief from minor aches and pains of sore muscles and joints associated with:

arthritis

backache

strains

sprains

Dosage and Administration (34068-7)

Directions

Adults and children 2 years of age and older:Rub a thin film over affected areas not more than daily: massage not necessary

Children under 2 years of age :Consult physician

Warnings and Precautions (34071-1)

For external use only

Flammable:Keep away from excessive heat or open flame

Section 50565-1 (50565-1)

Keep out of reach of children: If accidentally ingested, get medical help or contact a poison Control immediately (1800-222-1222)

Section 50567-7 (50567-7)

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 irritation develops ■do not bandage ■ wash hands alter use with cool water ■do not use with heating pad or device

Section 50569-3 (50569-3)

Ask a doctor before use if you have: sensitive skin

Stop use and ask a doctor if

condition worsens or symptoms persist for more than 7 days or clear up and occur again within a few days.

Section 51727-6 (51727-6)

camphor, carbopol 940, DMDM hydantoin, edetate disodium, FD&C yellow no. 5, FD&C blue no. 1, isopropyl alcohol, PEG 40

hydrogenated castor oil, propylene glycol, sodium hydroxide, water

Section 51945-4 (51945-4)

Section 53414-9 (53414-9)

If pregnant or breastfeeding, ask a health professional before use

Section 55105-1 (55105-1)

Topical Analgesic

Section 55106-9 (55106-9)

Menthol 4%


Advanced Ingredient Data


Raw Label Data

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