Drug Facts

Drug Facts
SPL v2
SPL
SPL Set ID 33f0f4b8-1aca-4b52-bec3-ded7ac08dcd7
Route
TOPICAL
Published
Effective Date 2023-09-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Melissa Officinalis Leaf (3 [hp_X]) Thuja Occidentalis Leaf Geranium Maculatum Root Calendula Officinalis Flower
Inactive Ingredients
Medium-chain Triglycerides Chamomile Flower Oil Lavender Oil Eucalyptus Oil Peppermint Oil

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2023-09-07

Description

Lemon Balm 3X HPUS                      Antiviral White Cedar 3X HPUS                      Anti-itch, Pain Reliever Spotted Geranium 3X HPUS             Antiseptic Pot Marigold 3X HPUS                     Healing

Purpose

Lemon Balm 3X HPUS                      Antiviral White Cedar 3X HPUS                      Anti-itch, Pain Reliever Spotted Geranium 3X HPUS             Antiseptic Pot Marigold 3X HPUS                     Healing


Medication Information

Purpose

Lemon Balm 3X HPUS                      Antiviral White Cedar 3X HPUS                      Anti-itch, Pain Reliever Spotted Geranium 3X HPUS             Antiseptic Pot Marigold 3X HPUS                     Healing

Description

Lemon Balm 3X HPUS                      Antiviral White Cedar 3X HPUS                      Anti-itch, Pain Reliever Spotted Geranium 3X HPUS             Antiseptic Pot Marigold 3X HPUS                     Healing

Uses

For treatment of genital herpes symptoms including itching, burning and/ or pain. During both the onset phase (tingle) and active outbreak (skin broken).

Section 50565-1

Section 55105-1

Warnings

For external use only.

Flammable, keep away from fire or flame.

Do not use

  • if you are allergic to any ingredient in this product
  • over large areas of the body

When using this product

  • apply only to affected area
  • do not use in or near eyes
  • avoid applying directly inside the vagina or rectum.
  • you may feel a brief burning sensation when you apply it. It should go away in a short time.
  • do not share or reuse an applicator, as spreading or reinfection may occur.
  •  do not remove cardboard sleeve after crushing,as cuts from glass may occur.

Stop use and ask a doctor if– your symptoms worsen or condition clears up and occurs again within a few days

Ask a doctor if– you are pregnant or nursing

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

Directions

Application instructions

  • Remove and reverse cardboard sleeve on applicator to expose swab.
  • Crush applicator to activate by squeezing on the “X” (in GENTANX) between thumb and forefinger until you hear a snap.
  • Rotate applicator with swab pointing downward and squeeze gently until the swab is saturated.
  • Discard after use.

At the first sign of genital herpes outbreak (tingle):

  • Clean the area of the tingle before applying.
  • Apply directly to genital area at the site of the tingle.
  • Repeat every 12 hours until all applicators are used.

After genital herpes blister erupts (skin broken):

  • Clean the area of the outbreak before applying.
  • Apply directly to the affected area of the genitals.
  • Repeat every 24 hours as needed

Children under 12: Ask a doctor

Product Label

Other Information

Store in a cool dry place away from sunlight.

Inactive Ingredients

Fractionated coconut oil, essential oil blend of chamomile, lavender, eucalyptus, and peppermint

Questions Or Comments?

Call 833-373-4020 or visit WWW.gentanx.com

Active Ingredients                              Purpose

Lemon Balm 3X HPUS                      Antiviral

White Cedar 3X HPUS                      Anti-itch, Pain Reliever

Spotted Geranium 3X HPUS             Antiseptic

Pot Marigold 3X HPUS                     Healing


Structured Label Content

Uses

For treatment of genital herpes symptoms including itching, burning and/ or pain. During both the onset phase (tingle) and active outbreak (skin broken).

Section 50565-1 (50565-1)

Section 55105-1 (55105-1)

Warnings

For external use only.

Flammable, keep away from fire or flame.

Do not use

  • if you are allergic to any ingredient in this product
  • over large areas of the body

When using this product

  • apply only to affected area
  • do not use in or near eyes
  • avoid applying directly inside the vagina or rectum.
  • you may feel a brief burning sensation when you apply it. It should go away in a short time.
  • do not share or reuse an applicator, as spreading or reinfection may occur.
  •  do not remove cardboard sleeve after crushing,as cuts from glass may occur.

Stop use and ask a doctor if– your symptoms worsen or condition clears up and occurs again within a few days

Ask a doctor if– you are pregnant or nursing

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

Directions

Application instructions

  • Remove and reverse cardboard sleeve on applicator to expose swab.
  • Crush applicator to activate by squeezing on the “X” (in GENTANX) between thumb and forefinger until you hear a snap.
  • Rotate applicator with swab pointing downward and squeeze gently until the swab is saturated.
  • Discard after use.

At the first sign of genital herpes outbreak (tingle):

  • Clean the area of the tingle before applying.
  • Apply directly to genital area at the site of the tingle.
  • Repeat every 12 hours until all applicators are used.

After genital herpes blister erupts (skin broken):

  • Clean the area of the outbreak before applying.
  • Apply directly to the affected area of the genitals.
  • Repeat every 24 hours as needed

Children under 12: Ask a doctor

Product Label (Product label)

Other Information (Other information)

Store in a cool dry place away from sunlight.

Inactive Ingredients (Inactive ingredients)

Fractionated coconut oil, essential oil blend of chamomile, lavender, eucalyptus, and peppermint

Questions Or Comments? (Questions or Comments?)

Call 833-373-4020 or visit WWW.gentanx.com

Active Ingredients                              Purpose (Active ingredients                              Purpose)

Lemon Balm 3X HPUS                      Antiviral

White Cedar 3X HPUS                      Anti-itch, Pain Reliever

Spotted Geranium 3X HPUS             Antiseptic

Pot Marigold 3X HPUS                     Healing


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)