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Valtrum® Us
SPL v1
SPL
SPL Set ID c4efa317-8dd1-49e1-b7ca-9df2147edd3e
Route
TOPICAL
Published
Effective Date 2024-01-03
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Camphor (synthetic) (3 g) Menthol (10 g) Salicylic Acid
Inactive Ingredients
Cetostearyl Alcohol Dmdm Hydantoin Glucosamine Sulfate Mineral Oil Polyoxyl 20 Cetostearyl Ether Polysorbate 20 Water Sodium Hydroxide Stearyl Alcohol .alpha.-tocopherol Acetate, D-

Identifiers & Packaging

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

Description

Camphor 3% Menthol 3% Methyl salicylate 10%

Purpose

Topical analgesic


Medication Information

Purpose

Topical analgesic

Description

Camphor 3% Menthol 3% Methyl salicylate 10%

Uses

For the temporary relief of minor aches and pains of muscles and joints associated with • Simple Backache • Arthritis • Strains • Bruises • Sprains

Section 42229-5

POWERFUL ANALGESIC

NEW CREAM

santo remedio

[email protected]

www.valtrum-santoremedio.com

Section 50565-1

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

Warnings

For external use only

• Avoid contact with eyes and mucous membranes • Do not use otherwise than as directed.

Caution: Discontinue use if excessive irritation of the skin develops.

When using this product:  • Do not bandage tightly • Do not apply to wounds or damaged skin.

Stop use and ask a doctor if: • Conditions worsens • Symptoms persist for more than 7 days or clear up and occur again within a few days.

If pregnant or breast-feeding , ask a health professional before use.

Packaging

Directions

Adults and Children 18 years of age and older: Apply to affected area not more than 3 to 4 times daily. Children under 18 years of age: Consult a doctor.

Drug Facts

Other Information

• Store in a cool dry place away from direct sunlight • Keep lid tightly closed

Active Ingredients

Camphor 3%

Menthol 3%

Methyl salicylate 10%

Inactive Ingredients:

Cetyl Stearyl Alcohol, DMDM Hydantoin, Glucosamine Sulfate, Mineral Oil, PEG-20 Cetyl/Stearyl Ether, Polysorbate 20, Purified Water, Sodium Hydroxide, Stearyl Alcohol, Tocopheryl Acetate.


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

Section 42229-5 (42229-5)

POWERFUL ANALGESIC

NEW CREAM

santo remedio

[email protected]

www.valtrum-santoremedio.com

Section 50565-1 (50565-1)

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

Purpose

Topical analgesic

Warnings

For external use only

• Avoid contact with eyes and mucous membranes • Do not use otherwise than as directed.

Caution: Discontinue use if excessive irritation of the skin develops.

When using this product:  • Do not bandage tightly • Do not apply to wounds or damaged skin.

Stop use and ask a doctor if: • Conditions worsens • Symptoms persist for more than 7 days or clear up and occur again within a few days.

If pregnant or breast-feeding , ask a health professional before use.

Packaging

Directions

Adults and Children 18 years of age and older: Apply to affected area not more than 3 to 4 times daily. Children under 18 years of age: Consult a doctor.

Drug Facts

Other Information (Other information)

• Store in a cool dry place away from direct sunlight • Keep lid tightly closed

Active Ingredients

Camphor 3%

Menthol 3%

Methyl salicylate 10%

Inactive Ingredients:

Cetyl Stearyl Alcohol, DMDM Hydantoin, Glucosamine Sulfate, Mineral Oil, PEG-20 Cetyl/Stearyl Ether, Polysorbate 20, Purified Water, Sodium Hydroxide, Stearyl Alcohol, Tocopheryl Acetate.


Advanced Ingredient Data


Raw Label Data

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