skinuva bruise - labeler lisitng

skinuva bruise - labeler lisitng
SPL v2
SPL
SPL Set ID 8bf57652-5750-4111-acef-45c5fdc676af
Route
oral
Published
Effective Date 2023-04-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
arnica montana (30 [hp_X])
Inactive Ingredients
sucrose magnesium stearate maltodextrin bromelains vitis vinifera seed ascorbic acid zinc oxide powdered cellulose rutin

Identifiers & Packaging

Pill Appearance
Shape: capsule Color: gray Size: 23 mm Score: 1
Marketing Status
unapproved homeopathic active Since 2023-04-10

Description

Active ingredients                                                  Purpose* Arnica montana 30X HPUS..............Bruising, swelling, pain and                                                                   anti-inflammatory HPUS indicates that the ingredient is officially included in the Homeopathic Pharmacopoeia of the United States *Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.


Medication Information

Warnings and Precautions

Warnings

Use only as directed. Consult your physician on the use of this product.

Keep out of reach of children.

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

Active Ingredient

Active ingredients                                                  Purpose*

Arnica montana 30X HPUS..............Bruising, swelling, pain and

                                                                  anti-inflammatory

HPUS indicates that the ingredient is officially included in the

Homeopathic Pharmacopoeia of the United States

*Claims based on traditional homeopathic practice, not accepted

medical evidence. Not FDA evaluated.

Indications and Usage

Uses Reduces pain, swelling, and discoloration from bruises.

Temporarily relieves muscle pain and stiffness due to surgery and injury.

Dosage and Administration

Directions

Take 2 capsules per day or as directed by your physician.

Description

Active ingredients                                                  Purpose* Arnica montana 30X HPUS..............Bruising, swelling, pain and                                                                   anti-inflammatory HPUS indicates that the ingredient is officially included in the Homeopathic Pharmacopoeia of the United States *Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

Section 50565-1

Keep out of reach of children.

Section 51727-6

Inactive ingredients ascorbic acid, bromelain,

cellulose (capsule shell), grape seed extract, magnesium stearate,

maltodextrin, rutin, sucrose, zinc oxide

Section 51945-4

SKINUVA

bruise

Arnica + Bromelain + Zinc

with other antioxidatants

*Reduces bruising, swelling, and pain

from surgeries, cosmetic procedures,

and injuries

14 Vegetarian Capsules

Homeopathic Medicine

Vegan | Gluten Free | Non-GMO

Section 53413-1

Dist. by: MD Medical Designs, Inc.,

Beverly Hills, CA 90212 ● Manufactured in U.S.A.

FDA Registered

www.skinuva.com

SOTC14Rev03

Section 55105-1

Uses Reduces pain, swelling, and discoloration from bruises.

Temporarily relieves muscle pain and stiffness due to surgery and injury

Section 60561-8

Other information Do not use if inner seal is broken.

Store in a cool, dark and dry place. If symptoms worsen or persist

for more than 7 days, consult your physician.


Structured Label Content

Warnings and Precautions (34071-1)

Warnings

Use only as directed. Consult your physician on the use of this product.

Keep out of reach of children.

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

Active Ingredient (55106-9)

Active ingredients                                                  Purpose*

Arnica montana 30X HPUS..............Bruising, swelling, pain and

                                                                  anti-inflammatory

HPUS indicates that the ingredient is officially included in the

Homeopathic Pharmacopoeia of the United States

*Claims based on traditional homeopathic practice, not accepted

medical evidence. Not FDA evaluated.

Indications and Usage (34067-9)

Uses Reduces pain, swelling, and discoloration from bruises.

Temporarily relieves muscle pain and stiffness due to surgery and injury.

Dosage and Administration (34068-7)

Directions

Take 2 capsules per day or as directed by your physician.

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 51727-6 (51727-6)

Inactive ingredients ascorbic acid, bromelain,

cellulose (capsule shell), grape seed extract, magnesium stearate,

maltodextrin, rutin, sucrose, zinc oxide

Section 51945-4 (51945-4)

SKINUVA

bruise

Arnica + Bromelain + Zinc

with other antioxidatants

*Reduces bruising, swelling, and pain

from surgeries, cosmetic procedures,

and injuries

14 Vegetarian Capsules

Homeopathic Medicine

Vegan | Gluten Free | Non-GMO

Section 53413-1 (53413-1)

Dist. by: MD Medical Designs, Inc.,

Beverly Hills, CA 90212 ● Manufactured in U.S.A.

FDA Registered

www.skinuva.com

SOTC14Rev03

Section 55105-1 (55105-1)

Uses Reduces pain, swelling, and discoloration from bruises.

Temporarily relieves muscle pain and stiffness due to surgery and injury

Section 60561-8 (60561-8)

Other information Do not use if inner seal is broken.

Store in a cool, dark and dry place. If symptoms worsen or persist

for more than 7 days, consult your physician.


Advanced Ingredient Data


Raw Label Data

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