Label: NASALGUARD ANTISEPTIC TOPICAL COOL MENTHOL- benzalkonium chloride gel
- NDC Code(s): 81907-101-01, 81907-101-03
- Packager: TRUTEK CORP.
- 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 6, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
-
DOSAGE & ADMINISTRATION
Directions
Apply to the outside of the nose as indicated below.
Begin by squeezing 1 to 2 pin-sized drops on your pointer finger.
Spread the gel between your pointer finger and thumb to ensure an even application.
Apply directly around the nostrils and above the upper lip.
Apply every 4 to 6 hours or as often as needed.
Reapply if nose or face becomes wet.
SAVE THIS (BOX) FOR REFERENCE
- INACTIVE INGREDIENT
- QUESTIONS
- STATEMENT OF IDENTITY
-
WARNINGS
For external use only
When using this product keep out of eyes. In case of contact with eyes, rinse eyes thoroughly with water.
Stop use and ask a doctor if
irritation and redness develop
condition persists for more than 72 hoursIf pregnant or breast-feeding, ask a health professional before use.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
- KEEP OUT OF REACH OF CHILDREN
- PREGNANCY OR BREAST FEEDING
- STOP USE
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
NASALGUARD ANTISEPTIC TOPICAL COOL MENTHOL
benzalkonium chloride gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:81907-101 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE 1.3 mg in 1000 mg Inactive Ingredients Ingredient Name Strength DIMETHICONE 350 (UNII: 2Y53S6ATLU) STEARETH-2 (UNII: V56DFE46J5) MENTHOL (UNII: L7T10EIP3A) WATER (UNII: 059QF0KO0R) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D) STEARETH-21 (UNII: 53J3F32P58) GLYCERIN (UNII: PDC6A3C0OX) PHENOXYETHANOL (UNII: HIE492ZZ3T) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) BEHENTRIMONIUM CHLORIDE (UNII: X7GNG3S47T) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:81907-101-01 1 in 1 BOX 03/01/2023 1 NDC:81907-101-03 3000 mg in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333E 10/24/2022 Labeler - TRUTEK CORP. (170729235) Registrant - TRUTEK CORP. (170729235) Establishment Name Address ID/FEI Business Operations TRUTEK CORP. 170729235 manufacture(81907-101)
