SOUTH MOON ESSENTIAL OIL FOR RESTORATION- glycerin liquid

SOUTH MOON Essential Oil For Restoration by

Drug Labeling and Warnings

SOUTH MOON Essential Oil For Restoration by is a Otc medication manufactured, distributed, or labeled by Shantou South Moon Biotechnology Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

CHLORHEXIDINE GLUCONATE、BORNEOL、TEA TREE OIL、CINNAMON BARK OIL

PURPOSE

1. Powerful antibacterial: effectively sterilizes, inhibits fungal growth, and quickly relieves onychomycosis.

2. Deep repair: Go deep into the root of the nail to promote healthy nail growth and repair damaged tissue.

3. Mild ingredients: It uses mild ingredients, does not contain harmful chemicals, is safe, mild and non-irritating.

4. Easy to use: easy to apply, quickly absorbed, and leaves no greasy feeling.

5. Provide long-term protection to prevent the recurrence of onychomycosis and keep nails healthy.

6. Mild formula, suitable for long-term use without side effects.

7. Provides anti-inflammatory effects, reduces redness, swelling and pain, and relieves discomfort.

8. Suitable for all nail types, comprehensive care for nail health.

9. Provides moisturizing effect and prevents nails from dryness and brittleness.

10. Can stimulate blood circulation and promote nail growth.

11. Contains nourishing ingredients to enhance nail toughness and prevent breakage.

12. No irritating smell, more comfortable to use.

13. Quick results, significantly improving onychomycosis in a short period of time.

14. Provide a protective layer to resist external pollution and bacterial invasion.

15. Suitable for use by the whole family, including the elderly and adults.

WHEN USING

Penetrates deeply into the base of nails to fight nail fungus; repairs damaged nail beds and promotes nail growth; penetrates deeply to restore nail luster.

WARNINGS

Please keep out of reach of children. Do not swallow.Please clean your hands before use to ensure the best results from the product. Discontinue use if signs of irritation or rash occur. Store in a cool and dry place.

DO NOT USE

Discontinue use if signs of irritation or rash occur.

STOP USE

Discontinue use if signs of irritation or rash occur.

KEEP OUT OF REACH OF CHILDREN

Please keep out of reach of children. Do not swallow.

STORAGE AND HANDLING

Store in a cool and dry place.

INACTIVE INGREDIENT

WATER、UREA、1,2-HEXANEDIOL、GLYCERIN、ALLANTOIN、ZINC OXIDE

INDICATIONS & USAGE

Penetrates deeply into the base of nails to fight nail fungus; repairs damaged nail beds and promotes nail growth; penetrates deeply to restore nail luster.

DOSAGE & ADMINISTRATION

Penetrates deeply into the base of nails to fight nail fungus; repairs damaged nail beds and promotes nail growth; penetrates deeply to restore nail luster.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SOUTH MOON ESSENTIAL OIL FOR RESTORATION 
glycerin liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84983-020
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TEA TREE OIL (UNII: VIF565UC2G) (TEA TREE OIL - UNII:VIF565UC2G)	TEA TREE OIL	0.004 mg  in 20 mg
BORNEOL (UNII: M89NIB437X) (BORNEOL - UNII:M89NIB437X)	BORNEOL	0.004 mg  in 20 mg
CINNAMON BARK OIL (UNII: XE54U569EC) (CINNAMON BARK OIL - UNII:XE54U569EC)	CINNAMON BARK OIL	0.004 mg  in 20 mg

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)	18.84 mg  in 20 mg
UREA (UNII: 8W8T17847W)	1 mg  in 20 mg
CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E)	0.004 mg  in 20 mg
GLYCERIN (UNII: PDC6A3C0OX)	0.02 mg  in 20 mg
ZINC OXIDE (UNII: SOI2LOH54Z)	0.004 mg  in 20 mg
ALLANTOIN (UNII: 344S277G0Z)	0.02 mg  in 20 mg
1,2-HEXANEDIOL (UNII: TR046Y3K1G)	0.1 mg  in 20 mg

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84983-020-01	20 mg in 1 BOTTLE, GLASS; Type 0: Not a Combination Product	01/26/2026

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M016	01/26/2026

Labeler - Shantou South Moon Biotechnology Co., Ltd. (457126192)

Establishment
Name	Address	ID/FEI	Business Operations
Shantou South Moon Biotechnology Co., Ltd.		457126192	manufacture(84983-020)