SPL v1
SPL
SPL Set ID 2ae64e09-670e-6f7f-e054-00144ff8d46c
Route
TOPICAL
Published
Effective Date 2016-02-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Hypericum Perforatum (0.36 g) Ruta Graveolens Whole (2.25 g) Bellis Perennis (1.44 g) Toxicodendron Pubescens Leaf (0.18 g) Menthol
Inactive Ingredients
Methyl Salicylate

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2016-02-08

Description

Adults: Apply externally twice daily to properly cleaned & dried affected portion. Children under 18 years: Please consult physician.


Medication Information

Warnings and Precautions

If symptons persist or worsen, a physician should be consulted. Keep out of reach of children. Do not use, if known sentivity to any of its ingredients exists. In case of emergency, contact a medical professional or posion control center immediately. For external use only. Replace cap tightly.

Indications and Usage

For the relief of joins pain, ligaments & tendons pain, Rheumatic pain, Sciatica, Neuralgia, Cramps in calves, Sprains, Muscular soreness.

Dosage and Administration

Adults: Apply externally twice daily to properly cleaned & dried affected portion.

Children under 18 years: Please consult physician.

Description

Adults: Apply externally twice daily to properly cleaned & dried affected portion. Children under 18 years: Please consult physician.

Section 51727-6

Vaseline base

Section 51945-4

Section 55105-1

Relieves arthritis pain

Relieves joint pain

Relieves pain

Section 55106-9

Rhus toxicondendron, Hypericum perforatum, Ruta graveolens, Bellis pernnis, Menthol


Structured Label Content

Indications and Usage (34067-9)

For the relief of joins pain, ligaments & tendons pain, Rheumatic pain, Sciatica, Neuralgia, Cramps in calves, Sprains, Muscular soreness.

Dosage and Administration (34068-7)

Adults: Apply externally twice daily to properly cleaned & dried affected portion.

Children under 18 years: Please consult physician.

Warnings and Precautions (34071-1)

If symptons persist or worsen, a physician should be consulted. Keep out of reach of children. Do not use, if known sentivity to any of its ingredients exists. In case of emergency, contact a medical professional or posion control center immediately. For external use only. Replace cap tightly.

Section 51727-6 (51727-6)

Vaseline base

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Relieves arthritis pain

Relieves joint pain

Relieves pain

Section 55106-9 (55106-9)

Rhus toxicondendron, Hypericum perforatum, Ruta graveolens, Bellis pernnis, Menthol


Advanced Ingredient Data


Raw Label Data

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