TERRASIL INFECTION PROTECTION WOUND CARE MAXIMUM STRENGTH- calendula, thuja occidentalis , symphytum officinale (comfrey) ointment
Aidance Skincare & Topical Solutions, LLC

Disclaimer: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

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terrasil INFECTION PROTECTION WOUND CARE Ointment MAXIMUM Strength

Active Ingredients

Calendula 1X HPUS, Thuja occidentalis 6X HPUS, Symphytum Officinale (Comfrey) 1X HPUS

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

Purpose

Calendula - Healing Agent, Thuja - Skin Eruption Relief, Symphytum Officinale (Comfrey)- Inflammatory Relief

Uses

Helps promote healing of cuts, scrapes and minor burns.

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. Consult a doctor before using 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

Directions

Wash and dry affected skin. Apply an ample amount of ointment. Cover

with a clean bandage. Repeat procedure 1 to 3 times daily until skin improves or as directed by a

doctor. 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 contain this ingredient.

PRINCIPAL DISPLAY PANEL - 50g Tube

terrasil

INFECTION PROTECTION WOUND CARE OINTMENT MAXIMUM STRENGTH

terrasil max

TERRASIL INFECTION PROTECTION WOUND CARE MAXIMUM STRENGTH
calendula, thuja occidentalis , symphytum officinale (comfrey) ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:24909-169
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD) (CALENDULA OFFICINALIS FLOWER - UNII:P0M7O4Y7YD)	CALENDULA OFFICINALIS FLOWER	1 [hp_X] in 50 g
THUJA OCCIDENTALIS WHOLE (UNII: 5HBV6WCE3N) (THUJA OCCIDENTALIS WHOLE - UNII:5HBV6WCE3N)	THUJA OCCIDENTALIS WHOLE	6 [hp_X] in 50 g
COMFREY (UNII: D05HXK6R3G) (COMFREY - UNII:D05HXK6R3G)	COMFREY	1 [hp_X] in 50 g

Ingredient Name	Strength
Inactive Ingredients
WHITE WAX (UNII: 7G1J5DA97F)
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)
TEA TREE OIL (UNII: VIF565UC2G)
STEARIC ACID (UNII: 4ELV7Z65AP)
ZINC OXIDE (UNII: SOI2LOH54Z)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:24909-169-14	14 g in 1 TUBE; Type 0: Not a Combination Product	07/01/2016
2	NDC:24909-169-50	50 g in 1 TUBE; Type 0: Not a Combination Product	07/01/2016
3	NDC:24909-169-20	200 g in 1 TUBE; Type 0: Not a Combination Product	07/01/2016

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		07/01/2016

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

Name	Address	ID/FEI	Business Operations
Establishment
Aidance Skincare & Topical Solutions, LLC		018950611	manufacture(24909-169) , label(24909-169)