Label: GENTANX- melissa officinalis leaf, thuja occidentalis leaf, geranium maculatum, calendula officinalis liquid
- NDC Code(s): 83243-002-01
- Packager: Outbreaks, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved homeopathic
DISCLAIMER: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.
Drug Label Information
Updated September 7, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredients Purpose
- PURPOSE
- Uses
-
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.
- KEEP OUT OF REACH OF CHILDREN
-
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
- Other information
- Inactive ingredients
- Questions or Comments?
- Product label
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INGREDIENTS AND APPEARANCE
GENTANX
melissa officinalis leaf, thuja occidentalis leaf, geranium maculatum, calendula officinalis liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:83243-002 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MELISSA OFFICINALIS LEAF (UNII: 50D2ZE9219) (MELISSA OFFICINALIS LEAF - UNII:50D2ZE9219) MELISSA OFFICINALIS LEAF 3 [hp_X] in 0.5 mL THUJA OCCIDENTALIS LEAF (UNII: 0T0DQN8786) (THUJA OCCIDENTALIS LEAF - UNII:0T0DQN8786) THUJA OCCIDENTALIS LEAF 3 [hp_X] in 0.5 mL GERANIUM MACULATUM ROOT (UNII: 93IXI5B6OJ) (GERANIUM MACULATUM ROOT - UNII:93IXI5B6OJ) GERANIUM MACULATUM ROOT 3 [hp_X] in 0.5 mL CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD) (CALENDULA OFFICINALIS FLOWER - UNII:P0M7O4Y7YD) CALENDULA OFFICINALIS FLOWER 3 [hp_X] in 0.5 mL Inactive Ingredients Ingredient Name Strength MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) CHAMOMILE FLOWER OIL (UNII: 60F80Z61A9) LAVENDER OIL (UNII: ZBP1YXW0H8) EUCALYPTUS OIL (UNII: 2R04ONI662) PEPPERMINT OIL (UNII: AV092KU4JH) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:83243-002-01 9 in 1 PACKAGE 09/07/2023 1 0.5 mL in 1 APPLICATOR; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 09/07/2023 Labeler - Outbreaks, Inc. (118810120)
