Benz Protect Geritrex LLC Geritrex LLC
<text/> <effectiveTime value="20171027"/> <subject> <manufacturedProduct> <manufacturedProduct> <code code="54162-099" codeSystem="2.16.840.1.113883.6.69"/> <name>Benz Protect</name> <formCode code="C42953" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="LIQUID"/> <asEntityWithGeneric> <genericMedicine> <name>BENZOIN RESIN</name> </genericMedicine> </asEntityWithGeneric> <ingredient classCode="ACTIB"> <quantity> <numerator unit="mg" value="100"/> <denominator unit="mL" value="1"/> </quantity> <ingredientSubstance> <code code="GK21SBA74R" codeSystem="2.16.840.1.113883.4.9"/> <name>BENZOIN RESIN</name> <activeMoiety> <activeMoiety> <code code="GK21SBA74R" codeSystem="2.16.840.1.113883.4.9"/> <name>BENZOIN RESIN</name> </activeMoiety> </activeMoiety> </ingredientSubstance> </ingredient> <ingredient classCode="IACT"> <ingredientSubstance> <code code="3K9958V90M" codeSystem="2.16.840.1.113883.4.9"/> <name>ALCOHOL</name> </ingredientSubstance> </ingredient> <ingredient classCode="IACT"> <ingredientSubstance> <code code="V5VD430YW9" codeSystem="2.16.840.1.113883.4.9"/> <name>ALOE</name> </ingredientSubstance> </ingredient> <ingredient classCode="IACT"> <ingredientSubstance> <code code="63V91G4W93" codeSystem="2.16.840.1.113883.4.9"/> <name>LIQUIDAMBAR ORIENTALIS RESIN</name> </ingredientSubstance> </ingredient> <ingredient classCode="IACT"> <ingredientSubstance> <code code="TD2LE91MBE" codeSystem="2.16.840.1.113883.4.9"/> <name>TOLU BALSAM</name> </ingredientSubstance> </ingredient> <asContent> <quantity> <numerator unit="mL" value="3"/> <denominator unit="1" value="1"/> </quantity> <containerPackagedProduct> <code code="54162-099-10" codeSystem="2.16.840.1.113883.6.69"/> <formCode code="C43200" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="POUCH"/> </containerPackagedProduct> <subjectOf> <marketingAct> <code code="C53292" codeSystem="2.16.840.1.113883.3.26.1.1"/> <statusCode code="active"/> <effectiveTime> <low value="20171027"/> </effectiveTime> </marketingAct> </subjectOf> <subjectOf> <characteristic classCode="OBS"> <code code="SPLCMBPRDTP" codeSystem="2.16.840.1.113883.1.11.19255"/> <value code="C112160" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="Type 0: Not a Combination Product" xsi:type="CE"/> </characteristic> </subjectOf> </asContent> <asContent> <quantity> <numerator unit="mL" value="150"/> <denominator unit="1" value="1"/> </quantity> <containerPackagedProduct> <code code="54162-099-50" codeSystem="2.16.840.1.113883.6.69"/> <formCode code="C43178" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="BOX"/> </containerPackagedProduct> <subjectOf> <marketingAct> <code code="C53292" codeSystem="2.16.840.1.113883.3.26.1.1"/> <statusCode code="active"/> <effectiveTime> <low value="20171027"/> </effectiveTime> </marketingAct> </subjectOf> <subjectOf> <characteristic classCode="OBS"> <code code="SPLCMBPRDTP" codeSystem="2.16.840.1.113883.1.11.19255"/> <value code="C112160" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="Type 0: Not a Combination Product" xsi:type="CE"/> </characteristic> </subjectOf> </asContent> </manufacturedProduct> <subjectOf> <approval> <id extension="part356" root="2.16.840.1.113883.3.149"/> <code code="C73604" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="OTC monograph not final"/> <author> <territorialAuthority> <territory> <code code="USA" codeSystem="2.16.840.1.113883.5.28"/> </territory> </territorialAuthority> </author> </approval> </subjectOf> <subjectOf> <marketingAct> <code code="C53292" codeSystem="2.16.840.1.113883.3.26.1.1"/> <statusCode code="active"/> <effectiveTime> <low value="20150731"/> </effectiveTime> </marketingAct> </subjectOf> <consumedIn> <substanceAdministration> <routeCode code="C38304" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="TOPICAL"/> </substanceAdministration> </consumedIn> </manufacturedProduct> </subject> </section> </component> <component> <section ID="Lee4a8d36-2c5f-4f7d-964c-e15b949a7be8"> <id root="34acc8b7-2de7-41c9-9a27-5a3eece36b41"/> <code code="55106-9" codeSystem="2.16.840.1.113883.6.1" displayName="OTC - ACTIVE INGREDIENT SECTION"/> <title>Active Ingredient Benzoin Compound Tincture (Benzoin, Aloe, Storax, Tolu, Balsam, Alcohol)
Intended Use Forms a coating over a wound For protecting recurring canker sores
Directions For adults and supervised children 2 years and older:
Dry affected area of skin or oral mucosa. Apply with a cotton
swab or gauze every 3-4 hours or as directed by your physician.
Warnings Do not Use this product for more than 7 days unless directed by a dentist or doctor Exceed recommended dosage
<content styleCode="bold">Stop use and ask a dentist or doctor if</content> Sore mouth symptoms do not improve in 7 days Irritation, pain, or redness persists or worsens Swelling, rash, or fever develop
<content styleCode="bold">Directions</content> Adults and children 6 months or age and older: Dry affected area of oral mucosa. Apply the swab applicator every 3-4 hours or as directed by physician. Children under 6 months of age: Consult a dentist or Doctor
Store at 20° to 25°C (68° to 77° F) [see USP Controlled Room Temperature] in tight, light-resistant containers. Avoid exposure
to direct sunlight or heat.
<content styleCode="bold">KEEP OUT OF REACH OF CHILDREN.</content> In case of accidental ingestions, seek professional assistance or contact a Poison Control Center immediately
If pregnant or breast-feeding, ask a health professional before use.
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