TERRASILMED INFECTION CONTROL AND PROTECTION- allantoin,benzethonium chloride ointment

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z), BENZETHONIUM CHLORIDE (UNII: PH41D05744) (BENZETHONIUM - UNII:1VU15B70BP)

Available from:

Aidance Skincare & Topical Solutions, LLC

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

Allantoin 0.5%                                             Skin Protectant Benzethonium Chloride 0.1%                        First Aid Antiseptic Helps protect skin and supports healing of minor cuts, scrapes, burns and wounds, including pressure sores, diabetic ulcers and cracked skin. Topical antiseptic to help decrease the risk of skin infection.

Authorization status:

OTC monograph not final

Summary of Product characteristics

TERRASILMED INFECTION CONTROL AND PROTECTION-
ALLANTOIN,BENZETHONIUM CHLORIDE 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 INGREDIENTS PURPOSE
Allantoin 0.5% Skin Protectant
Benzethonium Chloride 0.1% First Aid Antiseptic
_USES_
Helps protect skin and supports healing of minor cuts, scrapes, burns
and wounds,
including pressure sores, diabetic ulcers and cracked skin. Topical
antiseptic to help
decrease the risk of skin infection.
_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, consult a physician.
_DIRECTIONS_
Wash and dry affected skin. Apply a thin layer of product. Cover
affected area with a
clean bandage. Repeat procedure as directed by healthcare provider or
daily until
affected area improves. Store at room temperature. May stain fabrics.
_INACTIVE INGREDIENTS_
Beeswax, MCT (coconut oil), Petrolatum, Silver Stearate, Sorbic Acid
QUESTIONS?
401-432-7750 or www.aidance.com
PRODUCT LABEL
TERRASILMED INFECTION CONTROL AND PROTECTION
allantoin,benzethonium chloride ointment
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN OTC DRUG
ITEM CODE (SOURCE)
NDC:24909-025
ROUTE OF ADMINISTRATION
TOPICAL
Aidance Skincare & Topical Solutions, LLC
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRENGTH
ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z)
ALLANTOIN
0.5 g
in 100 g
BENZETHONIUM CHLORIDE (UNII: PH41D05744) (BENZETHONIUM -
UNII:1VU15B70BP)
BENZ ETHONIUM
CHLORIDE
0.1 g
in 100 g
INACTIVE INGREDIENTS
INGREDIENT NAME
STRENGTH
YELLOW WAX (UNII: 2ZA36H0S2V)
COCONUT OIL (UNII: Q9L0O73W7L)
PETROLA