Label: THE FACT-HFN COOLING ANTI-HAIR LOSS TONICGEL- menthol, salicylic acid, panthenol gel
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Contains inactivated NDC Code(s)
NDC Code(s): 77049-0011-1 - Packager: Interkos Co.,Ltd.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.
Drug Label Information
Updated January 20, 2022
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
-
INACTIVE INGREDIENT
Water
Alcohol
Glycerin
PEG-60 Hydrogenated Castor Oil
Tromethamine
Carbomer
Trideceth-10
Fragrance
Butylene Glycol
1,2-Hexanediol
Caprylyl Glycol
Brassica Oleracea Italica (Broccoli) Extract
Illicium Verum (Anise) Fruit Extract
Sodium Hyaluronate
Geraniol
Linalool
Citronellol
Hexyl Cinnamal
Limonene - PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
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WARNINGS
1. If you have any of the following side effetsc while using, you
should stop using, iatnd if you continue to use, iytour sympt
oms will worsen, so consult your dermatologist.
-If there are side effects such as red spots, swelling, itching, irrita
tion during use.
-If the application area has the above side efftesc
due to direct sunlight
2. Do not use on areas with wounds, eczema or dermatitis.
3. Precautions for stoarge and handling
- Be sure to close the cap taefr use.
- Do not store where children may reach.
- Store in a place with high or low tempaeturre and out of dire
ct sunlight.
4. In case of contact with eyes, rinse immediately and consult
a physician.
5. People who have ever had allergies, please consult your dotc
or or pharmacist before use
6. Do not use on children under 3 years ogfe a.
7. People with hypersensitivity to salicylic acid or who hasa bdei
tes, blood circulation disorders, renala filure, infection, redness,
those who are pregnant or may become pregnant should av
oid using the pdrouct as the current symptoms may worsen
a fter use, such as skin or body hypersensitivity or skin adverse
reatcions (edema, inflammation, etc.). So please avoid using it.
- Product Liability Act (PL Act): Before use, be sure to read the
instructions for use and precautions. - DOSAGE & ADMINISTRATION
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
THE FACT-HFN COOLING ANTI-HAIR LOSS TONICGEL
menthol, salicylic acid, panthenol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:77049-0011 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PANTHENOL (UNII: WV9CM0O67Z) (PANTHENOL - UNII:WV9CM0O67Z) PANTHENOL 0.3 g in 100 mL MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 0.04 g in 100 mL SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID 0.25 g in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:77049-0011-1 150 mL in 1 BOTTLE; Type 0: Not a Combination Product 01/21/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 01/21/2022 Labeler - Interkos Co.,Ltd. (689850314) Registrant - Interkos Co.,Ltd. (689850314) Establishment Name Address ID/FEI Business Operations Interkos Co.,Ltd. 689850314 manufacture(77049-0011)