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

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