Herpecin L by Knowlton Development Corporation Inc Herpecin L

Herpecin L by

Drug Labeling and Warnings

Herpecin L by is a Otc medication manufactured, distributed, or labeled by Knowlton Development Corporation Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

HERPECIN L- dimethicone and meradimate and octinoxate and octisalate and oxybenzone stick 
Knowlton Development Corporation Inc

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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Herpecin L

Skin protectant....Sunscreen

Dimethicone 1%

Meradimate 5%

Octinoxate 7.5%

Octisalate 5%

Oxybenzone 6%

Uses

• helps prevent sunburn on lips
  
• relieves dry chapped lips
  
• helps treat and relieve cold sores/fever blisters

Warnings

Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn where applied on lips, not skin cancer or early skin aging.

For external use only

Do not use

• on broken skin
  
• if you are allergic to any ingredient in this product

When using this product

• keep out of eyes. Rinse with water to remove.
  
• apply only to affected areas
  
• avoid applying directly inside your mouth
  
• do not share this product with anyone since this may spread infection

Stop use and ask a doctor if

• rash occurs, condition worsens or does not improve within 7 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 or over:

• apply liberally and evenly to affected area on lips at first sign of cold sore and 15 minutes before sun exposure
  
• rub in gently but completely
  
• for cracking or dryness continue to cover lips until absorbed
  
• reapply liberally as often as needed and at least every 2 hours when in sun
  
• use a water resistant sunscreen on lips if swimming or sweating

children under 12 years: ask a doctor

Other information

• protect the product in this container from excessive heat and direct sun

Inactive ingredients

helianthus annuus (hybrid sunflower) oil, petrolatum, ozokerite, mineral oil, microcrystalline wax, talc, titanium dioxide, beeswax, melissa officinalis (balm mint) extract, cetyl lactate, glyceryl laurate, flavor, lysine HCI, ascorbyl palmitate, tocopheryl acetate, pyridoxine HCI, panthenol, BHT (244-014)

PRINCIPAL DISPLAY PANEL

FAST ACTING RELIEF

Herpecin L ®

Real Relief from Real Medicine.

Helps Treat, Protect & Relieve

Cold Sores, Sun & Fever Blisters, Chapped Lips SPF 30

NET WT 0.1 OZ (2.8g)

HERPECIN L 
dimethicone and meradimate and octinoxate and octisalate and oxybenzone stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54565-3201
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	1 g  in 100 g
MERADIMATE (UNII: J9QGD60OUZ) (MERADIMATE - UNII:J9QGD60OUZ)	MERADIMATE	5 g  in 100 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7.5 g  in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g  in 100 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	6 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
HELIANTHUS ANNUUS FLOWERING TOP (UNII: BKJ0J3D1BP)
PETROLATUM (UNII: 4T6H12BN9U)
CERESIN (UNII: Q1LS2UJO3A)
MINERAL OIL (UNII: T5L8T28FGP)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
APIS MELLIFERA (UNII: 7S82P3R43Z)
MELISSA OFFICINALIS (UNII: YF70189L0N)
CETYL LACTATE (UNII: A7EVH2RK4O)
GLYCERYL LAURATE (UNII: Y98611C087)
LYSINE HYDROCHLORIDE (UNII: JNJ23Q2COM)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV)
PANTHENOL (UNII: WV9CM0O67Z)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54565-3201-2	1 in 1 CARTON	11/03/2017
1	NDC: 54565-3201-1	2.8 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	11/03/2017

Labeler - Knowlton Development Corporation Inc (204006464)

Establishment
Name	Address	ID/FEI	Business Operations
Knowlton Development Corporation Inc		204006464	manufacture(54565-3201) , analysis(54565-3201) , pack(54565-3201) , label(54565-3201)

Revised: 11/2019

Document Id: 96db980a-8bae-723b-e053-2995a90a7361

34390-5

Set id: 5d1a0eee-9d07-6442-e053-2a91aa0ab9e3

Version: 4

Effective Time: 20191108

 

Knowlton Development Corporation Inc