MedPath

Bestmade Natural Products Graphites

Graphites 30c

Approved
Approval ID

29a4557a-9476-3289-e063-6294a90a7a5e

Product Type

HUMAN OTC DRUG LABEL

Effective Date

May 27, 2025

Manufacturers
FDA

Bestmade Natural Products

DUNS: 047124582

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Graphites

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code82969-5056
Product Classification
G
Generic Name
Graphites
Product Specifications
Route of AdministrationORAL
Effective DateMay 27, 2025
FDA Product Classification

INGREDIENTS (3)

LACTOSE, UNSPECIFIED FORMInactive
Quantity: 30 [hp_C] in 30 [hp_C]
Code: J2B2A4N98G
Classification: IACT
SUCROSEInactive
Quantity: 30 [hp_C] in 30 [hp_C]
Code: C151H8M554
Classification: IACT
GRAPHITEActive
Quantity: 30 [hp_C] in 30 [hp_C]
Code: 4QQN74LH4O
Classification: ACTIB

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 12/19/2024

Entire package label

Graphites

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 12/19/2024

Best for

Temporarily relieves discomfort due to skin issues, particularly weeping rashes, accompanied by a discharge that typically occurs at the back of the ear.*

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 12/19/2024

Ingredients

Inactive: Sucrose/Lactose Pellets base to Preserve Remedy

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 12/19/2024

How to Use

Take with water 3-4 times a day. Ages 12 or older, 5 Pellets, Ages 12-2, 3 Pellets, Ages below 2, consult your Doctor.

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 12/19/2024

Active Ingredients: Graphites [HPUS] 30c potency

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 12/19/2024

Warnings:

Ask a professional before use if pregnant or breastfeeding or if you have severe symptoms.

Keep away from children. If you have a reaction to this product that is not positive, discontinue use. Store in a cool and dry place

*CLAIMS BASED ON TRADITIONAL HOMEOPATHIC PRACTICE, NOT ACCEPTED MEDICAL EVIDENCE NOT FDA EVALUATED.
This product is not intended to diagnose, treat, cure, or prevent any disease.

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 12/19/2024

Best for

Temporarily relieves discomfort due to skin issues, particularly weeping rashes, accompanied by a discharge that typically occurs at the back of the ear.*

WARNINGS SECTION

LOINC: 34071-1Updated: 12/19/2024

Warnings:

Ask a professional before use if pregnant or breastfeeding or if you have severe symptoms.

Keep away from children. If you have a reaction to this product that is not positive, discontinue use. Store in a cool and dry place

*CLAIMS BASED ON TRADITIONAL HOMEOPATHIC PRACTICE, NOT ACCEPTED MEDICAL EVIDENCE NOT FDA EVALUATED.
This product is not intended to diagnose, treat, cure, or prevent any disease.

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Bestmade Natural Products Graphites - FDA Drug Approval Details