Pain-a-trate Ultra

Drug Facts

Composition & Product

Active Ingredients

Camphor (synthetic) (3.4 g) Menthol (8.5 g) Salicylic Acid (25.5 g)

Inactive Ingredients

Trolamine Propanediol Steareth-2 Carbomer Interpolymer Type A (allyl Sucrose Crosslinked) Water Stearic Acid Tea Tree Oil Benzyl Alcohol Glyceryl Stearate Se Polysorbate 80 Steareth-21

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2021-10-01

Medication Information

Warnings and Precautions

Warnings

For external use only

Indications and Usage

Indications For the temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises, and sprains. Provides penetrating relief.

Dosage and Administration

Directions

apply to affected area with gentle massage
do not apply more than 3 to 4 times daily

Description

Active ingredients Camphor 4% Menthol 10% Methyl Salicylate 30%

Section 44425-7

Other information do not store above 95°F (35°C)

Section 50565-1

Keep out of reach of children to avoid accidental ingestion. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9

Stop use and ask a doctor if

condition worsens or symptoms persist for more than 7 days
symptoms clear up and occur again within a few days
excessive skin irritation occurs

Section 50567-7

When using this product

avoid contact with eyes or mucus membranes
do not bandage tightly

Section 50569-3

Ask a doctor before use if you have redness over the affected area.

Section 50570-1

Do not use

on wounds or damaged skin
with a heating pad
on a child under 12 years of age with arthritis-like conditions

Section 51727-6

Inactive ingredients acrylates/C10-30 alkyl acrylate crosspolymer, benzyl alcohol, deionized water, glyceryl monostearate SE, melaleuca alternifolia (tea tree) leaf oil, polysorbate 80, propanediol, steareth-2, steareth-21, stearic acid, triethanolamine

Section 51945-4

Section 55105-1

Purpose

Topical analgesic

Section 55106-9

Active ingredients

Camphor 4%

Menthol 10%

Methyl Salicylate 30%

Structured Label Content

Indications and Usage (34067-9)

Indications For the temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises, and sprains. Provides penetrating relief.

Dosage and Administration (34068-7)

Directions

apply to affected area with gentle massage
do not apply more than 3 to 4 times daily

Warnings and Precautions (34071-1)

Warnings

For external use only

Section 44425-7 (44425-7)

Other information do not store above 95°F (35°C)

Section 50565-1 (50565-1)

Keep out of reach of children to avoid accidental ingestion. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9 (50566-9)

Stop use and ask a doctor if

condition worsens or symptoms persist for more than 7 days
symptoms clear up and occur again within a few days
excessive skin irritation occurs

Section 50567-7 (50567-7)

When using this product

avoid contact with eyes or mucus membranes
do not bandage tightly

Section 50569-3 (50569-3)

Ask a doctor before use if you have redness over the affected area.

Section 50570-1 (50570-1)

Do not use

on wounds or damaged skin
with a heating pad
on a child under 12 years of age with arthritis-like conditions

Section 51727-6 (51727-6)

Inactive ingredients acrylates/C10-30 alkyl acrylate crosspolymer, benzyl alcohol, deionized water, glyceryl monostearate SE, melaleuca alternifolia (tea tree) leaf oil, polysorbate 80, propanediol, steareth-2, steareth-21, stearic acid, triethanolamine

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Purpose

Topical analgesic

Section 55106-9 (55106-9)

Active ingredients

Camphor 4%

Menthol 10%

Methyl Salicylate 30%

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"34067-9": "Indications For the temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises, and sprains. Provides penetrating relief.", "34068-7": "Directions apply to affected area with gentle massage do not apply more than 3 to 4 times daily", "34071-1": "Warnings For external use only", "44425-7": "Other information do not store above 95°F (35°C)", "50565-1": "Keep out of reach of children to avoid accidental ingestion. If swallowed, get medical help or contact a Poison Control Center right away.", "50566-9": "Stop use and ask a doctor if condition worsens or symptoms persist for more than 7 days symptoms clear up and occur again within a few days excessive skin irritation occurs", "50567-7": "When using this product avoid contact with eyes or mucus membranes do not bandage tightly", "50569-3": "Ask a doctor before use if you have redness over the affected area.", "50570-1": "Do not use on wounds or damaged skin with a heating pad on a child under 12 years of age with arthritis-like conditions", "51727-6": "Inactive ingredients acrylates/C10-30 alkyl acrylate crosspolymer, benzyl alcohol, deionized water, glyceryl monostearate SE, melaleuca alternifolia (tea tree) leaf oil, polysorbate 80, propanediol, steareth-2, steareth-21, stearic acid, triethanolamine", "55105-1": "Purpose Topical analgesic", "55106-9": "Active ingredients Camphor 4% Menthol 10% Methyl Salicylate 30%"}