Label: TECNU RASH RELIEF- grindelia robusta, calendula officinalis spray
- NDC Code(s): 51879-164-06
- Packager: Tec Laboratories Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved homeopathic
DISCLAIMER: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.
Drug Label Information
Updated July 5, 2023
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- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- DO NOT USE
- WHEN USING
- KEEP OUT OF REACH OF CHILDREN
- STOP USE
- DOSAGE & ADMINISTRATION
- STORAGE AND HANDLING
- INACTIVE INGREDIENT
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
TECNU RASH RELIEF
grindelia robusta, calendula officinalis sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51879-164 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GRINDELIA HIRSUTULA FLOWERING TOP (UNII: IDB0NAZ6AI) (GRINDELIA HIRSUTULA FLOWERING TOP - UNII:IDB0NAZ6AI) GRINDELIA HIRSUTULA FLOWERING TOP 1 [hp_X] in 1 mL CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD) (CALENDULA OFFICINALIS FLOWER - UNII:P0M7O4Y7YD) CALENDULA OFFICINALIS FLOWER 1 [hp_X] in 1 mL Inactive Ingredients Ingredient Name Strength ALCOHOL (UNII: 3K9958V90M) THYME OIL (UNII: 2UK410MY6B) POLYOXYL 35 CASTOR OIL (UNII: 6D4M1DAL6O) EDETATE DISODIUM (UNII: 7FLD91C86K) BENZETHONIUM CHLORIDE (UNII: PH41D05744) WATER (UNII: 059QF0KO0R) TEA TREE OIL (UNII: VIF565UC2G) MENTHOL (UNII: L7T10EIP3A) GLYCERIN (UNII: PDC6A3C0OX) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51879-164-06 177 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 07/12/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 07/12/2023 Labeler - Tec Laboratories Inc. (083647792) Establishment Name Address ID/FEI Business Operations Tec Laboratories Inc. 083647792 manufacture(51879-164)