Drug Facts:

Drug Facts:
SPL v2
SPL
SPL Set ID b82195bc-5727-49d1-91f9-086e2d032718
Route
TOPICAL
Published
Effective Date 2021-03-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Capsicum (3 [hp_X]) Pulsatilla Pratensis Whole (4 [hp_X]) Sanguinaria Canadensis Root
Inactive Ingredients
Water Phenoxyethanol Caprylyl Glycol Sorbic Acid Aloe Vera Leaf Oregano .alpha.-tocopherol Potassium Sorbate Dioscorea Villosa Tuber Black Cohosh Chaste Tree Fruit Lavandula Angustifolia Flower Sage Ascorbic Acid Hypericum Perforatum Alcohol Citric Acid Monohydrate

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Completed Since 2021-03-18 Until 2026-03-11

Description

(in each spray): 0.33% of Capsicum Annuum 3X, Pulsatilla (Pratensis) 4X, Sanguinaria Canadensis 3X.


Medication Information

Warnings and Precautions

For external use only. If pregnant, breast-feeding, taking birth control or on hormone replacement therapy, 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  Condition worsens - Symptoms last more than 7 days.

This product is not intended as an alternative hormone therapy.

Indications and Usage

May temporarily relieve menopausal disorders including flushes of heat, heavy menses with pain in left ovarian region and burning palms and soles. **

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

Dosage and Administration

Apply daily to neck, chest, abdomen, inner arms or inner thighs. Use as needed.

Description

(in each spray): 0.33% of Capsicum Annuum 3X, Pulsatilla (Pratensis) 4X, Sanguinaria Canadensis 3X.

Section 50565-1

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

Section 51727-6

Water, Wild Yam (Dioscorea Villosa) Root, Black Cohosh (Actaea Racemosa) Root, Chaste Tree (Vitex agnus-castus) Fruit, Lavender (Lavandula angustifolia) Buds, Sage (Salvia officinalis) Leaf, Ascorbic Acid, St John’s Wort (Hypericum Perforatum) Aerial Parts, Purified Water, Phenoxyethanol, Caprylyl Glycol, Sorbic Acid, Aloe Barbadensis Leaf Juice, Tocopherols (soy), Natural Plant Extract, Potassium Sorbate, Ethanol, Citric Acid.

Section 51945-4

peaceful mountain

THE HEIGHT OF HEALTH

hot flash rescue

homeopathic spray

soothing mist

2 fl. oz. (59 ml)

Section 53413-1

Dist. by Peaceful Mountain, Inc.

Woodbine, IA 51579

888-303-3388

www.peacefulmountain.com

no animal testing

Section 55105-1

May temporarily relieve menopausal disorders including flushes of heat, heavy menses with pain in left ovarian region and burning palms and soles. **

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

Section 55106-9

(in each spray): 0.33% of Capsicum Annuum 3X, Pulsatilla (Pratensis) 4X, Sanguinaria Canadensis 3X.


Structured Label Content

Indications and Usage (34067-9)

May temporarily relieve menopausal disorders including flushes of heat, heavy menses with pain in left ovarian region and burning palms and soles. **

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

Dosage and Administration (34068-7)

Apply daily to neck, chest, abdomen, inner arms or inner thighs. Use as needed.

Warnings and Precautions (34071-1)

For external use only. If pregnant, breast-feeding, taking birth control or on hormone replacement therapy, 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  Condition worsens - Symptoms last more than 7 days.

This product is not intended as an alternative hormone therapy.

Section 50565-1 (50565-1)

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

Section 51727-6 (51727-6)

Water, Wild Yam (Dioscorea Villosa) Root, Black Cohosh (Actaea Racemosa) Root, Chaste Tree (Vitex agnus-castus) Fruit, Lavender (Lavandula angustifolia) Buds, Sage (Salvia officinalis) Leaf, Ascorbic Acid, St John’s Wort (Hypericum Perforatum) Aerial Parts, Purified Water, Phenoxyethanol, Caprylyl Glycol, Sorbic Acid, Aloe Barbadensis Leaf Juice, Tocopherols (soy), Natural Plant Extract, Potassium Sorbate, Ethanol, Citric Acid.

Section 51945-4 (51945-4)

peaceful mountain

THE HEIGHT OF HEALTH

hot flash rescue

homeopathic spray

soothing mist

2 fl. oz. (59 ml)

Section 53413-1 (53413-1)

Dist. by Peaceful Mountain, Inc.

Woodbine, IA 51579

888-303-3388

www.peacefulmountain.com

no animal testing

Section 55105-1 (55105-1)

May temporarily relieve menopausal disorders including flushes of heat, heavy menses with pain in left ovarian region and burning palms and soles. **

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

Section 55106-9 (55106-9)

(in each spray): 0.33% of Capsicum Annuum 3X, Pulsatilla (Pratensis) 4X, Sanguinaria Canadensis 3X.


Advanced Ingredient Data


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