Recovery Care Products Arnica Silver Gel+ (72525-005)

Recovery Care Products Arnica Silver Gel+ (72525-005)
SPL v4
SPL
SPL Set ID eb54df52-829c-4bd6-9e16-0410c9960425
Route
TOPICAL
Published
Effective Date 2020-12-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Arnica Montana (6 [hp_X]) Calendula Officinalis Flowering Top
Inactive Ingredients
Aloe Vera Leaf Water Silver Phenoxyethanol Caprylyl Glycol Sorbic Acid Carbomer Interpolymer Type A (allyl Sucrose Crosslinked) Sodium Hydroxide Sodium Bicarbonate

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2020-12-08

Description

ARNICA MONTANA 6X CALENDULA OFFICINALIS 6X (*) The letter “HPUS” indicate that the components in this products are officially monographed in the Homeopathic Pharmacopoeia of the United States. These statements have not been evaluated by the Food and Drug administration. This product is not intended to diagnose, treat, cure or prevent any disease.

Purpose

Promotes rapid wound repair & maintains healthy tissue in times of physical stress


Medication Information

Purpose

Promotes rapid wound repair & maintains healthy tissue in times of physical stress

Description

ARNICA MONTANA 6X CALENDULA OFFICINALIS 6X (*) The letter “HPUS” indicate that the components in this products are officially monographed in the Homeopathic Pharmacopoeia of the United States. These statements have not been evaluated by the Food and Drug administration. This product is not intended to diagnose, treat, cure or prevent any disease.

Uses:

OTC use for abrasions, lacerations & soft tissue injuries. Under the supervision of a healthcare professional in the management of:

stage I-IV pressure ulcers, partial and full thickness wounds, diabetic foot and leg ulcers , grafted and donor sites, 1st and 2nd degree burns

Safe for a wide variety of dermal applications.

Wound Care: Prevents & treats infections - provides moist healing environment - controls odor, pus & body exudation – minimizes abnormal scarring – protects incisions

Soft Tissue Trauma: Reduces Bruising, swelling & pain

Redness & Itch Relief: related to wound healing, scabs, burns (including sunburn, radiation, lasers), rashes, dry skin, eczema, bug bites, dry skin, hives, stretch marks, hair removal

Hair Removal: Soothes, cools & relieves itch on shaven, waxed or lasered skin

Everyday Skin Care: Calms dry, sensitive, compromised, inflammatory & acne-prone skin

Anti-Aging: Regenerates, rejuvenates & revitalizes skin tissue. May reduce the appearance of fine lines & wrinkles and improve skin elasticity & resiliency

Section 50565-1

Keep out of reach of children.

Section 51945-4

Warnings:

For external use only. Do not get into eyes.

Directions:

Please adhere to your physician's protocol for this product. Cleanse or debride wound as necessary with mild soap such as RCP Gentle Cleanser Face & Body Foam Wash. Pat dry. Apply a generous layer over affected area with clean hands or medical gloves. Repeat as needed. For optimal results use in conjunction with RCP Arnica Montana+ & RCP Pure Bromelain.

Other Information:

Do not use if safety seal is broken or missing. Store at room temperature. Keep out of direct sunlight.

Inactive Ingredients:

Aloe Vera Leaf Juice Extract, Water, Elemental Silver (40ppm), Phenoxyethanol, Caprylyl Glycol, Sorbic Acid, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Sodium Hydroxide, Sodium Bicarbonate.

Active Ingredients (hpus*):

ARNICA MONTANA 6X

CALENDULA OFFICINALIS 6X

(*) The letter “HPUS” indicate that the components in this products are officially monographed in the Homeopathic Pharmacopoeia of the United States. These statements have not been evaluated by the Food and Drug administration.

This product is not intended to diagnose, treat, cure or prevent any disease.


Structured Label Content

Uses:

OTC use for abrasions, lacerations & soft tissue injuries. Under the supervision of a healthcare professional in the management of:

stage I-IV pressure ulcers, partial and full thickness wounds, diabetic foot and leg ulcers , grafted and donor sites, 1st and 2nd degree burns

Safe for a wide variety of dermal applications.

Wound Care: Prevents & treats infections - provides moist healing environment - controls odor, pus & body exudation – minimizes abnormal scarring – protects incisions

Soft Tissue Trauma: Reduces Bruising, swelling & pain

Redness & Itch Relief: related to wound healing, scabs, burns (including sunburn, radiation, lasers), rashes, dry skin, eczema, bug bites, dry skin, hives, stretch marks, hair removal

Hair Removal: Soothes, cools & relieves itch on shaven, waxed or lasered skin

Everyday Skin Care: Calms dry, sensitive, compromised, inflammatory & acne-prone skin

Anti-Aging: Regenerates, rejuvenates & revitalizes skin tissue. May reduce the appearance of fine lines & wrinkles and improve skin elasticity & resiliency

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 51945-4 (51945-4)

Purpose (PURPOSE)

Promotes rapid wound repair & maintains healthy tissue in times of physical stress

Warnings:

For external use only. Do not get into eyes.

Directions:

Please adhere to your physician's protocol for this product. Cleanse or debride wound as necessary with mild soap such as RCP Gentle Cleanser Face & Body Foam Wash. Pat dry. Apply a generous layer over affected area with clean hands or medical gloves. Repeat as needed. For optimal results use in conjunction with RCP Arnica Montana+ & RCP Pure Bromelain.

Other Information:

Do not use if safety seal is broken or missing. Store at room temperature. Keep out of direct sunlight.

Inactive Ingredients:

Aloe Vera Leaf Juice Extract, Water, Elemental Silver (40ppm), Phenoxyethanol, Caprylyl Glycol, Sorbic Acid, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Sodium Hydroxide, Sodium Bicarbonate.

Active Ingredients (hpus*): (Active Ingredients (HPUS*):)

ARNICA MONTANA 6X

CALENDULA OFFICINALIS 6X

(*) The letter “HPUS” indicate that the components in this products are officially monographed in the Homeopathic Pharmacopoeia of the United States. These statements have not been evaluated by the Food and Drug administration.

This product is not intended to diagnose, treat, cure or prevent any disease.


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