Drug Facts:

Drug Facts:
SPL v3
SPL
SPL Set ID e158a743-160f-446e-a0ea-a2ce566d866f
Route
TOPICAL
Published
Effective Date 2019-01-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Apis Mellifera (12 [hp_X]) Atropa Belladonna (15 [hp_X]) Oyster Shell Calcium Carbonate, Crude Daphne Mezereum Bark Toxicodendron Pubescens Leaf Astacus Astacus Gelsemium Sempervirens Root
Inactive Ingredients
Water Carbomer Interpolymer Type A (allyl Sucrose Crosslinked) Benzyl Alcohol Ethylhexylglycerin Tocopherol Sodium Hydroxide Aloe Vera Leaf Edetate Disodium

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Completed Since 2019-01-10 Until 2026-04-02

Description

(in gel):  1.43% of Apis Mellifica 12X, Astacus Fluviatilis 15X, Belladonna 12X, Calcarea Carbonica 12X, Gelsemium Sempervirens 15X, Mezereum 12X, Rhus Tox 12X.


Medication Information

Description

(in gel):  1.43% of Apis Mellifica 12X, Astacus Fluviatilis 15X, Belladonna 12X, Calcarea Carbonica 12X, Gelsemium Sempervirens 15X, Mezereum 12X, Rhus Tox 12X.

Warnings:

For external use only.

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

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

When using this product • Do not get into eyes.

Stop use and ask a doctor if • Conditions worsens • Symptoms last more than 7 days

Do not use if safety seal is broken or missing.

Questions:

Dist. by Peaceful Mountain, Inc.

Woodbine, IA 51579

888-303-3388

www.peacefulmountain.com

Directions:

Apply at least 3 times daily over the affected area.

Children under 12 years of age: Consult a doctor.

Indications:

May temporarily relieve itching, insect bites, poison ivy, rashes, eczema, hives, inflammation and irritated red skin.**

**Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

Active Ingredients:

(in gel): 1.43% of Apis Mellifica 12X, Astacus Fluviatilis 15X, Belladonna 12X, Calcarea Carbonica 12X, Gelsemium Sempervirens 15X, Mezereum 12X, Rhus Tox 12X.

Inactive Ingredients:

Aloe Barbadensis Leaf Juice, Purified Water, Benzyl Alcohol (and) Ethylhexylglycerin (and) Tocopherol, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Disodium EDTA, Sodium Hydroxide (Solution).

Package Label Display:

peaceful mountain

THE HEIGHT OF HEALTH

bite, bump and

rash relief

homeopathic

anti-itch gel

paraben-free

unscented • non-greasy

No menthol • no animal testing

Net wt. 2 oz. (57 g)

Keep Out of Reach of Children:

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


Structured Label Content

Warnings: (WARNINGS:)

For external use only.

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

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

When using this product • Do not get into eyes.

Stop use and ask a doctor if • Conditions worsens • Symptoms last more than 7 days

Do not use if safety seal is broken or missing.

Questions: (QUESTIONS:)

Dist. by Peaceful Mountain, Inc.

Woodbine, IA 51579

888-303-3388

www.peacefulmountain.com

Directions: (DIRECTIONS:)

Apply at least 3 times daily over the affected area.

Children under 12 years of age: Consult a doctor.

Indications: (INDICATIONS:)

May temporarily relieve itching, insect bites, poison ivy, rashes, eczema, hives, inflammation and irritated red skin.**

**Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

Active Ingredients: (ACTIVE INGREDIENTS:)

(in gel): 1.43% of Apis Mellifica 12X, Astacus Fluviatilis 15X, Belladonna 12X, Calcarea Carbonica 12X, Gelsemium Sempervirens 15X, Mezereum 12X, Rhus Tox 12X.

Inactive Ingredients: (INACTIVE INGREDIENTS:)

Aloe Barbadensis Leaf Juice, Purified Water, Benzyl Alcohol (and) Ethylhexylglycerin (and) Tocopherol, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Disodium EDTA, Sodium Hydroxide (Solution).

Package Label Display: (PACKAGE LABEL DISPLAY:)

peaceful mountain

THE HEIGHT OF HEALTH

bite, bump and

rash relief

homeopathic

anti-itch gel

paraben-free

unscented • non-greasy

No menthol • no animal testing

Net wt. 2 oz. (57 g)

Keep Out of Reach of Children: (KEEP OUT OF REACH OF CHILDREN:)

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


Advanced Ingredient Data


Raw Label Data

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