FASTRIN INFECTION CONTROL SKIN REPAIR- benzethonium chloride ointment

United States - English - NLM (National Library of Medicine)

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Active ingredient:
BENZETHONIUM CHLORIDE (UNII: PH41D05744) (BENZETHONIUM - UNII:1VU15B70BP)
Available from:
Aidance Skincare & Topical Solutions, LLC
INN (International Name):
BENZETHONIUM CHLORIDE
Composition:
BENZETHONIUM CHLORIDE 0.2 g in 100 g
Prescription type:
OTC DRUG
Therapeutic indications:
Topical Antiseptic Helps reduce the risk of skin infection.
Authorization status:
OTC monograph not final
Authorization number:
24909-602-10, 24909-602-50

FASTRIN INFECTION CONTROL SKIN REPAIR- 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.

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Drug Facts

Active Ingredient

Benzethonium Chloride 0.2%

Purpos e

Topical Antiseptic

Us es

Helps reduce 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, get medical help or contact a Poison Control Center immediately.

Directions

Clean and dry affected skin. For wound care, apply ointment liberally at least once daily, then cover with

sterile bandaging. For barrier protection, massage into skin 2 to 4 times daily. Store at room

temperature.

Inactive Ingredients

Beeswax, Cottonseed Oil, Jojoba Seed Oil, Magnesium Oxide, Manuka Honey, Silver Oxide, Zinc

Oxide

PRINCIPAL DISPLAY PANEL - 50g Tube

Fas trin

Infection Control

Skin Repair Ointment

Net WT 50g (1.76 oz.)

FASTRIN INFECTION CONTROL SKIN REPAIR

benzethonium chloride ointment

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:249 0 9 -6 0 2

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

BENZETHO NIUM CHLO RIDE (UNII: PH41D0 5744) (BENZETHONIUM -

UNII:1VU15B70 BP)

BENZETHONIUM

CHLORIDE

0 .2 g

in 10 0 g

Inactive Ingredients

Ingredient Name

Stre ng th

CO TTO NSEED O IL (UNII: H3E8 78 0 20 N)

HO NEY (UNII: Y9 H1V576 FH)

JO JO BA O IL (UNII: 724GKU717M)

MAGNESIUM O XIDE (UNII: 3A3U0 GI71G)

Aidance Skincare & Topical Solutions, LLC

SILVER O XIDE (UNII: 8 9 7WUN6 G6 T)

WHITE WAX (UNII: 7G1J5DA9 7F)

ZINC O XIDE (UNII: SOI2LOH54Z)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:249 0 9 -6 0 2-10

10 g in 1 JAR; Type 0 : No t a Co mbinatio n Pro duct

0 6 /0 1/20 17

2

NDC:249 0 9 -6 0 2-50

50 g in 1 TUBE; Type 0 : No t a Co mbinatio n Pro duct

0 6 /0 1/20 17

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph no t final

pa rt333A

0 6 /0 1/20 17

Labeler -

Aidance Skincare & T opical Solutions, LLC (018950611)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Aidance Skincare & To pical So lutio ns, LLC

0 18 9 50 6 11

manufacture(249 0 9 -6 0 2) , label(249 0 9 -6 0 2)

Revised: 6/2017

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