COLD SORE SUPPORT- allantoin, avobenzone, menthol, octinoxate and zinc oxide lipstick
MiraCell Inc

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MiraCell (as PLD) - COLD SORE SUPPORT (61223-101) - DELIST

Active Ingredients
Allantoin 0.75%
Avobenzone 2.5%
Menthol 1.0%
Octinoxate 5.5%
Zinc Oxide 3.5%

Purpose

Skin Protectant
Sunscreen
External Analgesic
Sunscreen
Sunscreen

Uses:

for the temporary relief of the pain and itching associatedwith fever blisters and cold sores
provides moderate protectionagainst sunburn
temporarily protects chapped or cracked lips

Warnings: external use only

Directions:

for cold sores/chapped lips, apply to lips with the first symptoms and as often as needed
for sunscreen, reapply every 2 hrs

Inactive Ingredients: Beeswax, Simmondsia Chinensis (Jojoba) Seed Oil, Butyrospermum Parkii (Shea) Butter, Camellia Kissi Oil, Helianthus Annuus (Sunflower) Seed Oil, L-Lysine, Euphorbia Cerifera (Candelilla) Wax, Melissa Officinalis Leaf Oil (Lemon Balm), Tocopherol, Aloe Barbadensis Leaf Extract, Calendula Officinalis Flower Extract, Echinacea Angustifolia Leaf Extract, Mentha Piperita (Peppermint) Oil, Stevia Rebaudiana Extract, Natural Lemon Flavor

Questions? 1-800-748-5040 www.MiraCell.com

Keep out of reach of children.

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COLD SORE SUPPORT
allantoin, avobenzone, menthol, octinoxate and zinc oxide lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:61223-101
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z)	ALLANTOIN	0.75 g in 100 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	2.5 g in 100 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	1 g in 100 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	5.5 g in 100 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	3.5 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
YELLOW WAX (UNII: 2ZA36H0S2V)
JOJOBA OIL (UNII: 724GKU717M)
SHEA BUTTER (UNII: K49155WL9Y)
CAMELLIA KISSII SEED OIL (UNII: 96HGN0T99A)
SUNFLOWER OIL (UNII: 3W1JG795YI)
LYSINE (UNII: K3Z4F929H6)
CANDELILLA WAX (UNII: WL0328HX19)
LEMON BALM OIL (UNII: MJ76269K9S)
TOCOPHEROL (UNII: R0ZB2556P8)
ALOE VERA WHOLE (UNII: KIZ4X2EHYX)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
ECHINACEA ANGUSTIFOLIA LEAF (UNII: FS7G8S6PJ8)
PEPPERMINT OIL (UNII: AV092KU4JH)
STEVIA REBAUDIANA WHOLE (UNII: 6U422Y08O2)
LEMON OIL (UNII: I9GRO824LL)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:61223-101-21	1 in 1 BOX	12/01/2013	12/31/2023
1	NDC:61223-101-11	4.5 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M016	12/01/2013	12/31/2023

Labeler - MiraCell Inc (150449945)

Revised: 4/2024

Document Id: 150ed7c8-13d3-9db9-e063-6394a90aa082

Set id: b1200a6a-254b-4032-89cd-025f91fcc754

Version: 2

Effective Time: 20240401

MiraCell Inc