Label: TEMPO BZK TOWELETTE- benzalkonium chloride cloth
TEMPO ALCOHOL PREP PAD- isopropyl alcohol swab
TEMPO STING RELIEF PAD- benzocaine, isopropyl alcohol swab
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Contains inactivated NDC Code(s)
NDC Code(s): 71756-8010-1, 71756-8050-1, 71756-8090-1 - Packager: Tempo Medical Products
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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 Label Information
Updated January 8, 2020
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
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Product Label for NDC 71756-8050-1 (BZK Towelette)
Do Not Use / Stop Use / Use
(Do not use)
- On irritated skin or over large areas of the body
- If contact occurs with eyes, flush eyes with water
(Stop use)
if irritation and redness develop. Consult your physician if the condition persists.
(Use)
Cleansing of hands, face and body. Air dries in seconds.
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Product Label for NDC 71756-8010-1 (Alcohol Prep Pad)
Do Not Use / Stop Use / Use
(Do not use)
- With electrocautery procedures
- If contact occurs with eyes, flush eyes with water
(Stop use)
if irritation and redness develop. Consult your physician if the condition persists.
(Use)
For preparation of the skin prior to an injection
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Product Label for NDC 71756-8090-1 (Sting Relief Pad)
Do Not Use / Stop Use / Use
(Do not use)
- With electrocautery procedures
- If contact occurs with eyes, flush eyes with water
(Stop use)
if irritation and redness develop. Consult your physician if the condition persists.
(Use)
For temporary relief of pain and itching associated with minor burns, scrapes and insect bites.
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INGREDIENTS AND APPEARANCE
TEMPO BZK TOWELETTE
benzalkonium chloride clothProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71756-8050 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE 0.13 mg in 100 mg Inactive Ingredients Ingredient Name Strength CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71756-8050-1 1.5 mg in 1 POUCH; Type 4: Device Coated/Impregnated/Otherwise Combined with Drug 12/27/2012 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 12/27/2012 TEMPO ALCOHOL PREP PAD
isopropyl alcohol swabProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71756-8010 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL 70 mL in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71756-8010-1 0.45 mL in 1 POUCH; Type 4: Device Coated/Impregnated/Otherwise Combined with Drug 03/08/2010 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 03/08/2010 TEMPO STING RELIEF PAD
benzocaine, isopropyl alcohol swabProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71756-8090 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE 6 mg in 100 mg ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL 70 mg in 100 mg Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71756-8090-1 0.45 mg in 1 POUCH; Type 4: Device Coated/Impregnated/Otherwise Combined with Drug 09/30/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 09/30/2016 Labeler - Tempo Medical Products (786585963)