TERRASIL FISSURES FORMULA- cocoa butter ointment

Pays: États-Unis

Langue: anglais

Source: NLM (National Library of Medicine)

Ingrédients actifs:

COCOA BUTTER (UNII: 512OYT1CRR) (COCOA BUTTER - UNII:512OYT1CRR)

Disponible depuis:

Aidance Skincare & Topical Solutions, LLC

Type d'ordonnance:

OTC DRUG

indications thérapeutiques:

Skin Protectant For the temporary relief of local itching and discomfort in the perianal area, associated with anorectal disorders. Temporarily forms a protective coating over inflamed tissues to help prevent drying of tissues. Temporarily protects irritated areas. Temporarily relieves burning.

Statut de autorisation:

OTC monograph final

Résumé des caractéristiques du produit

TERRASIL FISSURES FORMULA- COCOA BUTTER OINTMENT
AIDANCE SKINCARE & TOPICAL SOLUTIONS, LLC
_Disclaimer: Most OTC drugs are not reviewed and approved by FDA,
however they may be marketed if they_
_comply with applicable regulations and policies. FDA has not
evaluated whether this product complies._
----------
DRUG FACTS
ACTIVE INGREDIENT
Cocoa Butter 50%
PURPOS E
Skin Protectant
US ES
For the temporary relief of local itching and discomfort in the
perianal area, associated with anorectal
disorders. Temporarily forms a protective coating over inflamed
tissues to help prevent drying of
tissues. Temporarily protects irritated areas. Temporarily relieves
burning.
WARNINGS
FOR EXTERNAL AND/OR INTRARECTAL USE ONLY. WHEN USING THIS PRODUCT do
not exceed the recommended
daily dosage unless directed by a doctor. STOP USE AND ASK A DOCTOR IF
- bleeding occurs - condition
worsens or does not improve within 7 days. IF PREGNANT OR
BREAST-FEEDING, ask a health professional
before use.
KEEP OUT OF REACH OF CHILDREN.
If swallowed, get medical help or call a Poison Control Center right
away.
DIRECTIONS
Adults: If practical, cleanse the affected area before use. Apply to
the affected area up to 4 times daily,
especially at night, in the morning or after each bowel movement.
Regular use provides continual
therapy for relief of symptoms. Children under 12 years of age: ask a
doctor.
INACTIVE INGREDIENTS
beeswax (organic), bentonite (volcanic clay), calendula, chamomile,
jojoba seed oil, magnesium oxide,
peppermint oil, silver oxide, tea tree oil, zinc oxide.
PRINCIPAL DISPLAY PANEL - 14G LABEL
TERRASIL with Activated Minerals
FISSURES FORMULA
Coats. Soothes. Protects.
TERRASIL FISSURES FORMULA
cocoa butter ointment
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:249 0 9 -118
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRE NG TH
CO CO A BUTTER (UNII: 512OYT1CRR) (COCOA BUTTER - UNII:512OYT1CRR)
COCOA BUTTER
50 g in 10 0 g
INACTIVE INGREDIENTS
INGREDIENT N