TERRASIL BALANITIS RELIEF (sulfur, symphytum officinale- comfrey ointment

Drug Labeling and Warnings

Drug Details [pdf]

Active Ingredient

Sulfur 1X HPUS
Symphytum Officinale (Comfrey) 1X HPUS

Purpose

Sulfur - Rash Relief
Symphytum Officinale - Inflammatory Relief

Uses

Helps relieve irritated skin at the head of the penis.

KEEP OUT OF REACH OF CHILDREN

Warnings

For external use only.When using this product do not use in or near eyes. In case of contact, rinse eyes thoroughly with water.

Stop use and ask a doctor if - symptoms persists for more than 3 days - symptoms worsen - symptoms clear up and occur again within a few days.

Directions

Adults and children 2 years of age and older: Apply to affected area 2 to 3 times per day or as needed. Children under 2 years of age: Consult a doctor.

Inactive Ingredients

allantoin, beeswax (organic), bentonite (volcanic clay), cedarwood oil, coconut oil, cotton seed oil, jojoba seed oil, lavender oil, magnesium oxide, silver oxide, stearic acid, zinc oxide.

PRINCIPAL DISPLAY PANEL - 14g Tube

All Natural
terrasil®
BALANITIS RELIEF

INGREDIENTS AND APPEARANCE

TERRASIL BALANITIS RELIEF 
sulfur, symphytum officinale (comfrey) ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 24909-119
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70)	SULFUR	1 [hp_X]  in 1 g
SYMPHYTUM OFFICINALE WHOLE (UNII: H8FJJ6KX5Y) (SYMPHYTUM OFFICINALE WHOLE - UNII:H8FJJ6KX5Y)	SYMPHYTUM OFFICINALE WHOLE	1 [hp_X]  in 1 g

Inactive Ingredients
Ingredient Name	Strength
ALLANTOIN (UNII: 344S277G0Z)
BENTONITE (UNII: A3N5ZCN45C)
CEDRUS ATLANTICA BARK OIL (UNII: ZX5QRE4U60)
COCONUT OIL (UNII: Q9L0O73W7L)
COTTONSEED OIL (UNII: H3E878020N)
JOJOBA OIL (UNII: 724GKU717M)
LAVENDER OIL (UNII: ZBP1YXW0H8)
MAGNESIUM OXIDE (UNII: 3A3U0GI71G)
SILVER OXIDE (UNII: 897WUN6G6T)
STEARIC ACID (UNII: 4ELV7Z65AP)
WHITE WAX (UNII: 7G1J5DA97F)
ZINC OXIDE (UNII: SOI2LOH54Z)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 24909-119-14	14 g in 1 JAR; Type 0: Not a Combination Product	06/10/2014
2	NDC: 24909-119-44	44 g in 1 JAR; Type 0: Not a Combination Product	06/10/2014
3	NDC: 24909-119-15	14 g in 1 TUBE; Type 0: Not a Combination Product	12/29/2018
4	NDC: 24909-119-50	50 g in 1 TUBE; Type 0: Not a Combination Product	12/29/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		06/10/2014

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

Establishment
Name	Address	ID/FEI	Business Operations
Aidance Skincare & Topical Solutions, LLC		018950611	manufacture(24909-119) , label(24909-119)