OTC Medication Information: Herpecin L

HERPECIN L- dimethicone, meradimate, octinoxate, octisalate and oxybenzone stick
Focus Consumer Healthcare, LLC

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.

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

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HERPECIN L
dimethicone and meradimate and octinoxate and octisalate and oxybenzone stick
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:71687-7773
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DIMETHICONE (DIMETHICONE) DIMETHICONE 1 g in 100 g
MERADIMATE (MERADIMATE) MERADIMATE 5 g in 100 g
OCTINOXATE (OCTINOXATE) OCTINOXATE 7.5 g in 100 g
OCTISALATE (OCTISALATE) OCTISALATE 5 g in 100 g
OXYBENZONE (OXYBENZONE) OXYBENZONE 6 g in 100 g
Inactive Ingredients
Ingredient Name Strength
HELIANTHUS ANNUUS FLOWERING TOP
PETROLATUM
CERESIN
MINERAL OIL
MICROCRYSTALLINE WAX
TALC
TITANIUM DIOXIDE
APIS MELLIFERA
MELISSA OFFICINALIS
CETYL LACTATE
GLYCERYL LAURATE
LYSINE HYDROCHLORIDE
ASCORBYL PALMITATE
.ALPHA.-TOCOPHEROL ACETATE
PYRIDOXINE HYDROCHLORIDE
PANTHENOL
BUTYLATED HYDROXYTOLUENE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:71687-7773-2 1 TUBE in 1 CARTON contains a TUBE
1 2.8 g in 1 TUBE This package is contained within the CARTON (71687-7773-2)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part352 10/13/2017
Labeler — Focus Consumer Healthcare, LLC (080743737)

Revised: 09/2019 Focus Consumer Healthcare, LLC

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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