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

COLD SORE SUPPORT by

Drug Labeling and Warnings

COLD SORE SUPPORT by is a Otc medication manufactured, distributed, or labeled by MiraCell Inc, Health Specialty.com. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

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

PURPOSE

Purpose

Skin Protectant
Sunscreen
External Analgesic
Sunscreen
Sunscreen

INDICATIONS & USAGE

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

Warnings: external use only

DOSAGE & ADMINISTRATION

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 INGREDIENT

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

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

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
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

Inactive Ingredients
Ingredient Name	Strength
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61223-101-21	1 in 1 BOX
1	NDC: 61223-101-11	4.5 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	12/01/2013

Labeler - MiraCell Inc (150449945)

Establishment
Name	Address	ID/FEI	Business Operations
Health Specialty.com		794053863	manufacture(61223-101)