LORNAMEAD LYPSYL- petrolatum and menthol paste 
Lornamead

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.

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Drug Facts

Active ingredients

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

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

Uses

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 

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

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Carton label

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Tube Label

LORNAMEAD  LYPSYL
petrolatum paste
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:62721-8114
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PETROLATUM (PETROLATUM) PETROLATUM65.004 g  in 100 g
MENTHOL (MENTHOL) MENTHOL0.3 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
PROPYLPARABEN 
ALLANTOIN 
SHEA BUTTER 
YELLOW WAX 
DIMETHICONE 
PENTAERYTHRITYL TETRACAPRYLATE/TETRACAPRATE 
POLYISOBUTYLENE (2300 MW) 
ALOE VERA LEAF 
LEVOMENOL 
.ALPHA.-TOCOPHEROL ACETATE 
JOJOBA OIL 
LAVANDULA ANGUSTIFOLIA FLOWER 
CHAMOMILE 
TITANIUM DIOXIDE 
LYSINE 
HELIANTHUS ANNUUS FLOWERING TOP 
ZINC LACTATE 
ASCORBYL PALMITATE 
EUCALYPTUS GLOBULUS LEAF 
CAMPHOR (NATURAL) 
MELALEUCA ALTERNIFOLIA LEAF 
MENTHA PIPERITA 
Product Characteristics
ColoryellowScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62721-8114-91 in 1 CARTON
1NDC:62721-8114-28 g in 1 TUBE, WITH APPLICATOR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34602/01/2012
Labeler - Lornamead (126440440)
Registrant - Lornamead (126440440)
Establishment
NameAddressID/FEIBusiness Operations
Lornamead126440440manufacture(62721-8114), pack(62721-8114)

Revised: 3/2013
Document Id: 486da846-a7dc-4b1c-a271-07e75aaa440b
Set id: 1790899e-67ae-4515-9042-736a46fd606a
Version: 1
Effective Time: 20130306
 
Lornamead