TERRASIL SKIN REPAIR MAXIMUM STRENGTH- calendula, symphytum officinale, thuja occidentalis ointment

Drug Labeling and Warnings

Drug Details [pdf]

Active Ingredients and Purpose

Calendula 1X HPUS - Healing Agent, Symphytum Officinale (Comfrey) lX HPUS - Inflammatory Relief, Thuja Occidentalis 6X HPUS - Skin Eruption Relief.

The letters HPUS indicate the component(s) in this product is (are) officially monographed in the Homeopathic Pharmacopeia of the United States.

PURPOSE

Uses

• Topical antiseptic helps decrease the risk of skin infection. Helps protect skin and supports healing of minor burns, skin lesions, sores, blisters, cracked or damaged skin and lips.
• Also helps protect from the drying effects of wind and cold weather.

Warnings

For external use only. When using this product, do not get into eyes. Stop use and ask a doctor if condition worsens, symptoms last more than 7 days or clear up and occur again within a few days.

Do not use on deep or puncture wounds, animal bites or serious burns.

Keep out of reach of children. If swallowed, call poison control or seek medical help.

KEEP OUT OF REACH OF CHILDREN

Directions

Wash and dry affected skin. Apply a thin layer of Terrasil. Repeat procedure 2 to 3 times daily until skin improves. Store at room temperature. May stain fabrics.

Inactive Ingredients

beeswax (organic), bentonite (volcanic clay)**, cotton seed oil, jojoba seed oil, magnesium oxide, peppermint oil, sage oil, silver oxide, tea tree oil, vegetable stearic acid (naturally sourced), zinc oxide.

**may contant this ingredient.

PRINCIPAL DISPLAY PANEL

All Natural
terrasil®
ANTI-BACTERIAL
SKIN REPAIR OINTMENT
MAXIMUM STRENGTH
with Activated Minerals®

INGREDIENTS AND APPEARANCE

TERRASIL SKIN REPAIR  MAXIMUM STRENGTH
calendula, symphytum officinale, thuja occidentalis ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 24909-181
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD) (CALENDULA OFFICINALIS FLOWER - UNII:P0M7O4Y7YD)	CALENDULA OFFICINALIS FLOWER	1 [hp_X]  in 1 g
COMFREY ROOT (UNII: M9VVZ08EKQ) (COMFREY ROOT - UNII:M9VVZ08EKQ)	COMFREY ROOT	1 [hp_X]  in 1 g
THUJA OCCIDENTALIS WHOLE (UNII: 5HBV6WCE3N) (THUJA OCCIDENTALIS WHOLE - UNII:5HBV6WCE3N)	THUJA OCCIDENTALIS WHOLE	6 [hp_X]  in 1 g

Inactive Ingredients
Ingredient Name	Strength
BENTONITE (UNII: A3N5ZCN45C)
COTTONSEED OIL (UNII: H3E878020N)
JOJOBA OIL (UNII: 724GKU717M)
MAGNESIUM OXIDE (UNII: 3A3U0GI71G)
PEPPERMINT OIL (UNII: AV092KU4JH)
SAGE OIL (UNII: U27K0H1H2O)
SILVER OXIDE (UNII: 897WUN6G6T)
STEARIC ACID (UNII: 4ELV7Z65AP)
TEA TREE OIL (UNII: VIF565UC2G)
WHITE WAX (UNII: 7G1J5DA97F)
ZINC OXIDE (UNII: SOI2LOH54Z)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 24909-181-50	50 g in 1 TUBE; Type 0: Not a Combination Product	01/01/2017
2	NDC: 24909-181-14	14 g in 1 TUBE; Type 0: Not a Combination Product	01/01/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		01/01/2017

Labeler - Aidance Skincare & Topical Solutions, LLC (018950611)

Establishment
Name	Address	ID/FEI	Business Operations
Aidance Skincare & Topical Solutions, LLC		018950611	manufacture(24909-181) , label(24909-181)