Label: ECO LIPS MENTHOL MEDICATED LIP BALM- menthol stick
- NDC Code(s): 75071-010-01
- Packager: Eco Lips, Inc.
- 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 22, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
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DOSAGE & ADMINISTRATION
Directions
adults & children 2 years of age and older:
- clean the affected area
- apply a small amount of product to affected area not more than 3 to 4 times daily
- rub in genlty; may be covered with a sterile bandage
- wash hands before and after applying balm
- do not share product with anyone else
children under 12 years of age: ask a doctor
- STORAGE AND HANDLING
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INACTIVE INGREDIENT
Inactive ingredients *Beeswax, *Calendula Flower Extract, *Chamomile Extract, ⴕ*Cocoa Butter, ⴕ*Coconut Oil, *Echinacea Root Extract, *Eucalyptus Oil, *Licorice Root Extract, *Lemon Balm Leaf Extract, *Peppermint Oil, *Tea Tree Oil, Mixed Tocopherols. *Certified Organic Ingredient ⴕFair Trade Certified™ by Fair Trade USA.® 20% of Product.
- QUESTIONS
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SPL UNCLASSIFIED SECTION
Menthol Medicated Fever Blister/Cold Sore Treatment
Net Wt 0.15 Oz (4.25 g)
Certified Organic by Oregon Tilth
Manufactured in USA
PlantPod Plast Free Tube
Fast Relief of Itching & Pain
With Tea Tree, Lemon Balm & Peppermint
Soothe and protect painful fever blisters and cold sores with this special medicated lip care blend. Menthol and lemon balm work together providing a cool soothing effect to promote relief.
Eco Lips, Inc. Cedar Rapids, IA 52402
Ecolips.com
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ECO LIPS MENTHOL MEDICATED LIP BALM
menthol stickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:75071-010 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 0.0425 g in 4.25 g Inactive Ingredients Ingredient Name Strength SUNFLOWER OIL (UNII: 3W1JG795YI) TEA TREE OIL (UNII: VIF565UC2G) CHAMOMILE FLOWER OIL (UNII: 60F80Z61A9) COCOA BUTTER (UNII: 512OYT1CRR) ROSEMARY OIL (UNII: 8LGU7VM393) PEPPERMINT OIL (UNII: AV092KU4JH) COCONUT OIL (UNII: Q9L0O73W7L) TOCOPHEROL (UNII: R0ZB2556P8) CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD) YELLOW WAX (UNII: 2ZA36H0S2V) MELISSA OFFICINALIS LEAF OIL (UNII: PTP6R7263M) EUCALYPTUS OIL (UNII: 2R04ONI662) ECHINACEA ANGUSTIFOLIA ROOT (UNII: D982V7VT3P) ST. JOHN'S WORT (UNII: UFH8805FKA) LICORICE (UNII: 61ZBX54883) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:75071-010-01 1 in 1 BOX 06/05/2023 1 4.25 g 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 part348 06/05/2023 Labeler - Eco Lips, Inc. (138732727) Establishment Name Address ID/FEI Business Operations Eco Lips, Inc. 138732727 manufacture(75071-010)
