NDC 72934-6100

HYDROCORTISONE 0.5% / HYDROQUINONE 4% / TRETINOIN 0.025%

Hydrocortisone 0.5% / Hydroquinone 4% / Tretinoin 0.025%

HYDROCORTISONE 0.5% / HYDROQUINONE 4% / TRETINOIN 0.025% is a Topical Emulsion in the Human Prescription Drug category. It is labeled and distributed by Sincerus Florda, Llc. The primary component is Hydrocortisone; Hydroquinone; Tretinoin.

• Product ID: 72934-6100_891bbc1e-51e3-f1f9-e053-2a95a90a5aed
• NDC: 72934-6100
• Product Type: Human Prescription Drug
• Proprietary Name: HYDROCORTISONE 0.5% / HYDROQUINONE 4% / TRETINOIN 0.025%
• Generic Name: Hydrocortisone 0.5% / Hydroquinone 4% / Tretinoin 0.025%
• Dosage Form: Emulsion
• Route of Administration: TOPICAL
• Marketing Start Date: 2019-05-17
• Marketing Category: UNAPPROVED DRUG OTHER / UNAPPROVED DRUG OTHER
• Labeler Name: Sincerus Florda, LLC
• Substance Name: HYDROCORTISONE; HYDROQUINONE; TRETINOIN
• Active Ingredient Strength: 1 g/100g; g/100g; g/100g
• Pharm Classes: Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA],Melanin Synthesis Inhibitor [EPC],Melanin Synthesis Inhibitors [MoA],Depigmenting Activity [PE],Retinoid [EPC],Retinoids [CS]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 72934-6100-2

30 g in 1 BOTTLE, PUMP (72934-6100-2)

• Marketing Start Date: 2019-05-17
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 72934-6100-2 [72934610002]

HYDROCORTISONE 0.5% / HYDROQUINONE 4% / TRETINOIN 0.025% EMULSION

• Marketing Category: unapproved drug other
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2019-05-17

Drug Details

Active Ingredients

Ingredient	Strength
HYDROCORTISONE	.5 g/100g

OpenFDA Data

• SPL SET ID: 891bbc1e-51e2-f1f9-e053-2a95a90a5aed
• Manufacturer:
  • Sincerus Florda, LLC
• UNII:
  • 5688UTC01R
  • XV74C1N1AE
  • WI4X0X7BPJ

Pharmacological Class

• Corticosteroid [EPC]
• Corticosteroid Hormone Receptor Agonists [MoA]
• Melanin Synthesis Inhibitor [EPC]
• Melanin Synthesis Inhibitors [MoA]
• Depigmenting Activity [PE]
• Retinoid [EPC]
• Retinoids [CS]
• Corticosteroid [EPC]
• Corticosteroid Hormone Receptor Agonists [MoA]
• Melanin Synthesis Inhibitor [EPC]
• Melanin Synthesis Inhibitors [MoA]
• Depigmenting Activity [PE]
• Retinoid [EPC]
• Retinoids [CS]

NDC Crossover Matching brand name "HYDROCORTISONE 0.5% / HYDROQUINONE 4% / TRETINOIN 0.025%" or generic name "Hydrocortisone 0.5% / Hydroquinone 4% / Tretinoin 0.025%"

NDC	Brand Name	Generic Name
72934-6099	HYDROCORTISONE 0.5% / HYDROQUINONE 4% / TRETINOIN 0.025%	HYDROCORTISONE 0.5% / HYDROQUINONE 4% / TRETINOIN 0.025%
72934-6100	HYDROCORTISONE 0.5% / HYDROQUINONE 4% / TRETINOIN 0.025%	HYDROCORTISONE 0.5% / HYDROQUINONE 4% / TRETINOIN 0.025%
72934-6101	HYDROCORTISONE 0.5% / HYDROQUINONE 4% / TRETINOIN 0.025%	HYDROCORTISONE 0.5% / HYDROQUINONE 4% / TRETINOIN 0.025%
72934-6102	HYDROCORTISONE 0.5% / HYDROQUINONE 4% / TRETINOIN 0.025%	HYDROCORTISONE 0.5% / HYDROQUINONE 4% / TRETINOIN 0.025%