LORNAMEAD LYPSYL- petrolatum paste

Lornamead by

Drug Labeling and Warnings

Lornamead by is a Otc medication manufactured, distributed, or labeled by Lornamead. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Petrolatum 62% ......................................................... Skin Protectant

Menthol 0.6% .............................................................External Analgesic

Uses

• For the temporary relief of pain & itching associated with cold sores and fever blisters
• Temporarily protects and helps relieve chapped or cracked lips

WARNINGS

For External Use Only. When using this product do not use in or near the eyes. If contact occurs, rinse eyes thoroughly with water and obtain medical attention. Stop use and ask a doctor if condition worsens or if symptoms persist for more than 7 days or clear up and occur again within a few days.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Adults and children 12 years of age and older: Apply directly to cold sore or fever blister 1 to 3 times daily

Children under 2 years of age: Consult a doctor 

DOSAGE & ADMINISTRATION

Apply directly to cold sore or fever blister 1 to 3 times daily Children under 2 years of age: ask a doctor

Other Information

Store between 15 - 30C (59-86F)

Inactive ingredients

Beeswax, Polyisobutene, Hydrogenatede Polyisobutene, Ethylene/Propylene/Styrene Copolymer, Butylene/Ethylene/Styrene Copolymer, Pentaerythrityl Tetracaprylate/Tetracaprate, Eucalyptus Globulus Leaf Extract, Melaleuca Alternifolia (Tea Tree) Extract, Ceretified Organic Butyrospermum Parkii (Shea Butter) Fruit, Aloe Barbadensis Leaf Extract, Lysine, Dimethicone, Allantoin, Tocopheryl Acetate (Vitamin E Acetate), Bisabolol, Chamomilla Recutita (Matricaria) Extract, Lavandula Angustifolia (Lavender) Extract, Mentha Piperita (Peppermint) Oil, Camphor, Zinc Lactate, Ascorbyl Palmitate, Propolis Extract, Helianthus Annuus (Sunflower) Seed Extract, Propylparaben, Titanium Dioxide

PRINCIPAL DISPLAY PANEL

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INGREDIENTS AND APPEARANCE

LORNAMEAD  LYPSYL
petrolatum paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62721-8114
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U)	PETROLATUM	65.004 g  in 100 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	0.3 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
PROPYLPARABEN (UNII: Z8IX2SC1OH)
ALLANTOIN (UNII: 344S277G0Z)
SHEA BUTTER (UNII: K49155WL9Y)
YELLOW WAX (UNII: 2ZA36H0S2V)
DIMETHICONE (UNII: 92RU3N3Y1O)
PENTAERYTHRITYL TETRACAPRYLATE/TETRACAPRATE (UNII: 832C4KF14X)
POLYISOBUTYLENE (2300 MW) (UNII: DSQ2V1DD1K)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
LEVOMENOL (UNII: 24WE03BX2T)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
JOJOBA OIL (UNII: 724GKU717M)
LAVANDULA ANGUSTIFOLIA FLOWER (UNII: 19AH1RAF4M)
CHAMOMILE (UNII: FGL3685T2X)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
LYSINE (UNII: K3Z4F929H6)
HELIANTHUS ANNUUS FLOWERING TOP (UNII: BKJ0J3D1BP)
ZINC LACTATE (UNII: 2GXR25858Y)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
EUCALYPTUS GLOBULUS LEAF (UNII: S546YLW6E6)
CAMPHOR (NATURAL) (UNII: N20HL7Q941)
MELALEUCA ALTERNIFOLIA LEAF (UNII: G43C57162K)
MENTHA PIPERITA (UNII: 79M2M2UDA9)

Product Characteristics
Color	yellow	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62721-8114-9	1 in 1 CARTON
1	NDC: 62721-8114-2	8 g in 1 TUBE, WITH APPLICATOR

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part346	02/01/2012

Labeler - Lornamead (126440440)

Registrant - Lornamead (126440440)

Establishment
Name	Address	ID/FEI	Business Operations
Lornamead		126440440	manufacture(62721-8114) , pack(62721-8114)