Arnica 9009p

Arnica 9009p
SPL v2
SPL
SPL Set ID 9e3be074-b2cd-9b1f-e053-2a95a90ac7b2
Route
ORAL
Published
Effective Date 2020-01-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Arnica Montana (30 [hp_C])
Inactive Ingredients
Sucrose

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2020-01-01

Description

Trauma; Injuries; Bruises; Exhaustion; Headache; Sprains; Wounds.

Purpose

Trauma; Injuries; Bruises; Exhaustion; Headache; Sprains; Wounds


Medication Information

Purpose

Trauma; Injuries; Bruises; Exhaustion; Headache; Sprains; Wounds

Description

Trauma; Injuries; Bruises; Exhaustion; Headache; Sprains; Wounds.

Package Label

Warnings Section

Warning: Keep out of reach of children. Do not use if tamper - evident seal is broken or missing. If symptoms worsen or persist for more than a few days, consult a doctor. If pregnant or breast-feeding, ask a doctor before use.

Questions Section

newtonlabs.net – Questions? 800.448.7256

Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA 30013

Otc Purpose Section

Trauma; Injuries; Bruises; Exhaustion; Headache; Sprains; Wounds

Inactive Ingredient Section

Inactive Ingredients: Gluten-free, non-GMO, organic beet-derived sucrose (lactose free) pellets

Indications & Usage Section

Trauma; Injuries; Bruises; Exhaustion; Headache; Sprains; Wounds.

Dosage & Administration Section

Directions: Ages 12 and up, take 6 pellets by mouth, (ages 0 to 11, give 3 pellets) as needed or as directed by a health professional. Under age 2, crush/dissolve pellets in purified water. Sensitive persons begin with 1 pellet and gradually increase to full dose.

Otc Active Ingredient Section

Arnica montana 30c

Otc Pregnancy Or Breast Feeding Section

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

Otc Keep Out of Reach of Children Section

Keep out of reach of children.


Structured Label Content

Package Label (PACKAGE LABEL)

Warnings Section (WARNINGS SECTION)

Warning: Keep out of reach of children. Do not use if tamper - evident seal is broken or missing. If symptoms worsen or persist for more than a few days, consult a doctor. If pregnant or breast-feeding, ask a doctor before use.

Questions Section (QUESTIONS SECTION)

newtonlabs.net – Questions? 800.448.7256

Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA 30013

Otc Purpose Section (OTC - PURPOSE SECTION)

Trauma; Injuries; Bruises; Exhaustion; Headache; Sprains; Wounds

Inactive Ingredient Section (INACTIVE INGREDIENT SECTION)

Inactive Ingredients: Gluten-free, non-GMO, organic beet-derived sucrose (lactose free) pellets

Indications & Usage Section (INDICATIONS & USAGE SECTION)

Trauma; Injuries; Bruises; Exhaustion; Headache; Sprains; Wounds.

Dosage & Administration Section (DOSAGE & ADMINISTRATION SECTION)

Directions: Ages 12 and up, take 6 pellets by mouth, (ages 0 to 11, give 3 pellets) as needed or as directed by a health professional. Under age 2, crush/dissolve pellets in purified water. Sensitive persons begin with 1 pellet and gradually increase to full dose.

Otc Active Ingredient Section (OTC - ACTIVE INGREDIENT SECTION)

Arnica montana 30c

Otc Pregnancy Or Breast Feeding Section (OTC - PREGNANCY OR BREAST FEEDING SECTION)

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

Otc Keep Out of Reach of Children Section (OTC - KEEP OUT OF REACH OF CHILDREN SECTION)

Keep out of reach of children.


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)