Label: GUARDRX UNSCENTED EXTRA STRENGTH- hand sanitizer liquid
GUARDRX LAVENDER PEPPERMINT EXTRA STRENGTH- hand sanitizer liquid
GUARDRX RED THYME EXTRA STRENGTH- hand sanitizer liquid
-
Contains inactivated NDC Code(s)
NDC Code(s): 74306-133-02, 74306-133-04, 74306-133-08, 74306-134-02, view more74306-134-04, 74306-134-08, 74306-135-02, 74306-135-04, 74306-135-08 - Packager: GPS Associates
- 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 May 4, 2020
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- Purpose:
- Uses:
- WARNINGS:
- Directions:
- STORAGE AND HANDLING
- Inactive Ingredients:
- ACTIVE INGREDIENT
- Purpose:
- Uses:
- WARNINGS:
- Directions:
- STORAGE AND HANDLING
- Inactive Ingredients:
- ACTIVE INGREDIENT
- Purpose:
- Uses:
- WARNINGS:
- Directions:
- STORAGE AND HANDLING
- Inactive Ingredients:
- 59 mL NDC: 74306-133-02
- 118 mL NDC: 74306-133-04
- 236 mL NDC: 74306-133-08
- 59 mL NDC: 74306-134-02
- 118 mL NDC: 74306-134-04
- 236 mL NDC: 74306-134-08
- 59 mL NDC: 74306-135-02
- 118 mL NDC: 74306-135-04
- 236 mL NDC: 74306-135-08
-
INGREDIENTS AND APPEARANCE
GUARDRX UNSCENTED EXTRA STRENGTH
hand sanitizer liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:74306-135 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 70 mL in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) .ALPHA.-TOCOPHEROL, DL- (UNII: 7QWA1RIO01) GLYCERIN (UNII: PDC6A3C0OX) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:74306-135-02 59 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 05/04/2020 2 NDC:74306-135-04 118 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 05/04/2020 3 NDC:74306-135-08 236 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 05/04/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 05/04/2020 GUARDRX LAVENDER PEPPERMINT EXTRA STRENGTH
hand sanitizer liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:74306-134 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 70 mL in 100 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) WATER (UNII: 059QF0KO0R) .ALPHA.-TOCOPHEROL, DL- (UNII: 7QWA1RIO01) LAVENDER OIL (UNII: ZBP1YXW0H8) PEPPERMINT OIL (UNII: AV092KU4JH) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:74306-134-02 59 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 05/04/2020 2 NDC:74306-134-04 118 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 05/04/2020 3 NDC:74306-134-08 236 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 05/04/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 05/04/2020 GUARDRX RED THYME EXTRA STRENGTH
hand sanitizer liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:74306-133 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 70 mL in 100 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) WATER (UNII: 059QF0KO0R) THYME OIL (UNII: 2UK410MY6B) ORANGE OIL (UNII: AKN3KSD11B) .ALPHA.-TOCOPHEROL, DL- (UNII: 7QWA1RIO01) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:74306-133-02 59 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 05/04/2020 2 NDC:74306-133-04 118 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 05/04/2020 3 NDC:74306-133-08 236 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 05/04/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 05/04/2020 Labeler - GPS Associates (096942063) Registrant - GPS Associates, LLC (096942063) Establishment Name Address ID/FEI Business Operations GPS Associates 096942063 manufacture(74306-133, 74306-134, 74306-135)