SPL v5
SPL
SPL Set ID cb98d828-0000-498a-9a3e-42059e087d56
Route
TOPICAL
Published
Effective Date 2010-08-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Aconitum Napellus (12 [hp_C]) Hypericum Perforatum Lycopodium Clavatum Spore Phosphorus Toxicodendron Pubescens Leaf Claviceps Purpurea Sclerotium
Inactive Ingredients
Alcohol Bergamot Oil Eucalyptus Oil Tea Tree Oil

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2010-08-20

Description

Topical analgesic


Medication Information

Warnings and Precautions
  • Do not drink
  • For external use only
  • Avoid eye/mouth contact
  • Strong floral aroma
  • Do not use on broken skin
Discontinue use if skin irritation develops.



If condition worsens or if symptoms persist for more than 2 weeks or if you suspect you are diabetic consult a doctor.

Indications and Usage

Uses: For rapid, temporary relief of the symptoms of pain, including shooting, burning, tingling and stabbing pains in the hand and feet.

Dosage and Administration

Directions: Apply a small amount to the affected area up to 4 times daily

Description

Topical analgesic

Section 44425-7

Store at room temperature 59-86 degrees F (15-30 degrees C)

Section 50565-1

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

Section 51727-6

bergamot oil, ethyl alcohol, eucalyptus oil, geranium oil, lavender oil, tea tree oil

Section 51945-4

Nerve Pain Relief

from Nerve Related Pain:

  • Shooting Pain
  • Tingling Pain
  • Burning Soles




Section 53414-9

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

Section 55105-1

Topical analgesic

Section 55106-9


Aconitum napellus 12C, Hypericum perforatum 12C, Lycopodium clavatum 12C, Phosphorus 12C, Rhus toxicodendron 12C, Secale Cornatum 12C


Structured Label Content

Indications and Usage (34067-9)

Uses: For rapid, temporary relief of the symptoms of pain, including shooting, burning, tingling and stabbing pains in the hand and feet.

Dosage and Administration (34068-7)

Directions: Apply a small amount to the affected area up to 4 times daily

Warnings and Precautions (34071-1)
  • Do not drink
  • For external use only
  • Avoid eye/mouth contact
  • Strong floral aroma
  • Do not use on broken skin
Discontinue use if skin irritation develops.



If condition worsens or if symptoms persist for more than 2 weeks or if you suspect you are diabetic consult a doctor.

Section 44425-7 (44425-7)

Store at room temperature 59-86 degrees F (15-30 degrees C)

Section 50565-1 (50565-1)

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

Section 51727-6 (51727-6)

bergamot oil, ethyl alcohol, eucalyptus oil, geranium oil, lavender oil, tea tree oil

Section 51945-4 (51945-4)

Nerve Pain Relief

from Nerve Related Pain:

  • Shooting Pain
  • Tingling Pain
  • Burning Soles




Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)

Topical analgesic

Section 55106-9 (55106-9)


Aconitum napellus 12C, Hypericum perforatum 12C, Lycopodium clavatum 12C, Phosphorus 12C, Rhus toxicodendron 12C, Secale Cornatum 12C


Advanced Ingredient Data


Raw Label Data

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