Satohap Lotion

Satohap Lotion
SPL v4
SPL
SPL Set ID 348fde05-2797-4410-a1b2-99e64187c4fe
Route
TOPICAL
Published
Effective Date 2012-05-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (10 g) Camphor (synthetic) (5 g) Levomenthol (4 g)
Inactive Ingredients
Edetate Disodium Alcohol Propylene Glycol Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 1991-02-05

Description

Active ingredients dl-Camphor 5% l-Menthol 4% Methyl salicylate 10%


Medication Information

Warnings and Precautions

Warnings

For external use only



Indications and Usage

Uses

temporarily relieves minor aches and pains of muscles and joints due to

■ backache     ■ arthritis     ■ strains     ■ bruises     ■ sprains



Dosage and Administration

Directions

■ adults and children 2 years of age and over: apply to affected area not more than 3 to 4 times daily.

■ children under 2 years of age: do not use, ask a doctor.

Description

Active ingredients dl-Camphor 5% l-Menthol 4% Methyl salicylate 10%

Section 50565-1

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

Section 50566-9

Stop use and ask a doctor if



■ excessive irritation develops



■ condition worsens



■ symptoms persist for more than 7 days



■ symptoms clear up and occur again within a few days



■ when using for pain of arthritis if:



■ pain persist for more than 10 days



■ redness is present



■ in conditions affecting children under 12 years of age





Section 50567-7

When using this product



■ avoid contact with the eyes and mucous membranes



■ do not bandage tightly

Section 50570-1

Do not use



■ on wounds



■ on damaged or irritated skin





Section 51727-6

Inactive ingredients

edetate disodium, alcohol, propylene glycol, water



Section 51945-4

Section 55105-1

Purpose

dl-Camphor    External analgesic

l-Menthol    External analgesic

Methyl salicylate    External analgesic



Section 55106-9

Active ingredients

dl-Camphor 5%

l-Menthol 4%

Methyl salicylate 10%


Structured Label Content

Indications and Usage (34067-9)

Uses

temporarily relieves minor aches and pains of muscles and joints due to

■ backache     ■ arthritis     ■ strains     ■ bruises     ■ sprains



Dosage and Administration (34068-7)

Directions

■ adults and children 2 years of age and over: apply to affected area not more than 3 to 4 times daily.

■ children under 2 years of age: do not use, ask a doctor.

Warnings and Precautions (34071-1)

Warnings

For external use only



Section 50565-1 (50565-1)

Keep out of reach of children. 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



■ excessive irritation develops



■ condition worsens



■ symptoms persist for more than 7 days



■ symptoms clear up and occur again within a few days



■ when using for pain of arthritis if:



■ pain persist for more than 10 days



■ redness is present



■ in conditions affecting children under 12 years of age





Section 50567-7 (50567-7)

When using this product



■ avoid contact with the eyes and mucous membranes



■ do not bandage tightly

Section 50570-1 (50570-1)

Do not use



■ on wounds



■ on damaged or irritated skin





Section 51727-6 (51727-6)

Inactive ingredients

edetate disodium, alcohol, propylene glycol, water



Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Purpose

dl-Camphor    External analgesic

l-Menthol    External analgesic

Methyl salicylate    External analgesic



Section 55106-9 (55106-9)

Active ingredients

dl-Camphor 5%

l-Menthol 4%

Methyl salicylate 10%


Advanced Ingredient Data


Raw Label Data

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