SPL v6
SPL
SPL Set ID 9a6f173c-7dcf-4a1c-8817-486eeace753d
Route
TOPICAL
Published
Effective Date 2011-07-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Aesculus Hippocastanum Flower (4 [hp_X]) Aloe (2 [hp_X]) Arnica Montana (3 [hp_X]) Berberis Vulgaris Root Bark Calendula Officinalis Flowering Top Salicylic Acid Zinc Cation
Inactive Ingredients
Water Propylene Glycol Polysorbate 20 Glycerin Sodium Bicarbonate Dimethyl Sulfone Citric Acid Monohydrate Potassium Sorbate Benzyl Alcohol Avocado Oil Alpha-tocopherol

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2010-09-01

Description

Aesculus hippocastanum 4x, Aloe socotrina 4x, Arnica montana 4x, Berberis vulgaris 4x, Calendula officinalis 4x, Salicylicum acidum 2x, Zincum metallicum 3x


Medication Information

Warnings and Precautions

For external use only.

Indications and Usage

Temporarily relieves symptoms of minor burns, superficial scalds, sunburn, and other minor skin irritations such as:

  • redness
  • stinging
  • burning
  • itching
  • minor pain
  • dryness
  • as per homeopathic materia medica

Dosage and Administration

Directions

  • Adults and children 3 years of age and older:

  • clean the burned area(s)
  • apply topically as needed not more than 12 times daily
  • area may be covered with a sterile bandage
  • children under 3 years of age: consult a physician



Description

Aesculus hippocastanum 4x, Aloe socotrina 4x, Arnica montana 4x, Berberis vulgaris 4x, Calendula officinalis 4x, Salicylicum acidum 2x, Zincum metallicum 3x

Section 44425-7
  • store at room temperature
  • Tamper Evident:  Do not use if imprinted seal around cap is broken or missing.

Section 50565-1

Keep out of the 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

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

Section 50567-7

When using this product

  • use only as directed
  • test on a small area before use.  This product may cause allergic reaction in some individuals.
  • wash hands before and after using
  • avoid contact with eyes or mucous membranes
  • do not bandage tightly

Section 50569-3

Ask a doctor before use in case of deep or puncture wounds, animal bites, or serious burns.

Section 50570-1

Do not

  • use if you are allergic to salicylates (although this product does not contain aspirin)
  • use in the eyes
  • apply over large areas of the body
  • use longer than 1 week unless directed by a doctor
  • ingest



Section 51727-6

deionized water, propylene glycol, polysorbate 20, glycerine, sodium bicarbonate, MSM, Dimethylaminoethanol, citric acid, potassium sorbate, benzyl alcohol, trace minerals (trona), avocado oil, and vitamin E

Section 51945-4

Section 53413-1
Questions?



1.800.321.3740

Mon-Fri, 9am-5pm

Section 55105-1

Aesculus hippocastanum...................................................Venous Stasis

Aloe socotrina...........................................................................Redness

Arnica montana...........................................................................Burning

Berberis vulgaris..........................................................................Burning

Calendula officinalis.....................................................................Healing

Salicylicum acidum.......................................................Burning and Heat

Zincum metallicum.............................................................Pain Reliever

Section 55106-9

Aesculus hippocastanum 4x, Aloe socotrina 4x, Arnica montana 4x, Berberis vulgaris 4x, Calendula officinalis 4x, Salicylicum acidum 2x, Zincum metallicum 3x


Structured Label Content

Indications and Usage (34067-9)

Temporarily relieves symptoms of minor burns, superficial scalds, sunburn, and other minor skin irritations such as:

  • redness
  • stinging
  • burning
  • itching
  • minor pain
  • dryness
  • as per homeopathic materia medica

Dosage and Administration (34068-7)

Directions

  • Adults and children 3 years of age and older:

  • clean the burned area(s)
  • apply topically as needed not more than 12 times daily
  • area may be covered with a sterile bandage
  • children under 3 years of age: consult a physician



Warnings and Precautions (34071-1)

For external use only.

Section 44425-7 (44425-7)
  • store at room temperature
  • Tamper Evident:  Do not use if imprinted seal around cap is broken or missing.

Section 50565-1 (50565-1)

Keep out of the 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

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

Section 50567-7 (50567-7)

When using this product

  • use only as directed
  • test on a small area before use.  This product may cause allergic reaction in some individuals.
  • wash hands before and after using
  • avoid contact with eyes or mucous membranes
  • do not bandage tightly

Section 50569-3 (50569-3)

Ask a doctor before use in case of deep or puncture wounds, animal bites, or serious burns.

Section 50570-1 (50570-1)

Do not

  • use if you are allergic to salicylates (although this product does not contain aspirin)
  • use in the eyes
  • apply over large areas of the body
  • use longer than 1 week unless directed by a doctor
  • ingest



Section 51727-6 (51727-6)

deionized water, propylene glycol, polysorbate 20, glycerine, sodium bicarbonate, MSM, Dimethylaminoethanol, citric acid, potassium sorbate, benzyl alcohol, trace minerals (trona), avocado oil, and vitamin E

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)
Questions?



1.800.321.3740

Mon-Fri, 9am-5pm

Section 55105-1 (55105-1)

Aesculus hippocastanum...................................................Venous Stasis

Aloe socotrina...........................................................................Redness

Arnica montana...........................................................................Burning

Berberis vulgaris..........................................................................Burning

Calendula officinalis.....................................................................Healing

Salicylicum acidum.......................................................Burning and Heat

Zincum metallicum.............................................................Pain Reliever

Section 55106-9 (55106-9)

Aesculus hippocastanum 4x, Aloe socotrina 4x, Arnica montana 4x, Berberis vulgaris 4x, Calendula officinalis 4x, Salicylicum acidum 2x, Zincum metallicum 3x


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