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NDC 42851-0035-81 ZO Skin Health Pigment Control plus Brightening Creme Hydroquinone plus Vitamin C 0.04 mg/mL Details
ZO Skin Health Pigment Control plus Brightening Creme Hydroquinone plus Vitamin C 0.04 mg/mL
ZO Skin Health Pigment Control plus Brightening Creme Hydroquinone plus Vitamin C is a TOPICAL EMULSION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by ZO Skin Health, Inc.. The primary component is HYDROQUINONE.
Product Information
| NDC | 42851-0035 |
|---|---|
| Product ID | 42851-035_dd2fe1d6-cadc-4299-e053-2995a90a4f3e |
| Associated GPIs | |
| GCN Sequence Number | n/a |
| GCN Sequence Number Description | n/a |
| HIC3 | n/a |
| HIC3 Description | n/a |
| GCN | n/a |
| HICL Sequence Number | n/a |
| HICL Sequence Number Description | n/a |
| Brand/Generic | n/a |
| Proprietary Name | ZO Skin Health Pigment Control plus Brightening Creme Hydroquinone plus Vitamin C |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Hydroquinone |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | EMULSION |
| Route | TOPICAL |
| Active Ingredient Strength | 0.04 |
| Active Ingredient Units | mg/mL |
| Substance Name | HYDROQUINONE |
| Labeler Name | ZO Skin Health, Inc. |
| Pharmaceutical Class | Depigmenting Activity [PE], Melanin Synthesis Inhibitor [EPC], Melanin Synthesis Inhibitors [MoA] |
| DEA Schedule | n/a |
| Marketing Category | UNAPPROVED DRUG OTHER |
| Application Number | n/a |
| Listing Certified Through | 2024-12-31 |
Package
Package Images
NDC 42851-0035-81 (42851003581)
| NDC Package Code | 42851-035-81 |
|---|---|
| Billing NDC | 42851003581 |
| Package | 1 BOTTLE, PLASTIC in 1 CARTON (42851-035-81) / 81 mL in 1 BOTTLE, PLASTIC |
| Marketing Start Date | 2018-05-01 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL d7bfa71b-ddce-437e-abf9-2837af82c54d Details
DOSAGE AND ADMINISTRATION
WARNINGS
Keep out of reach of children. For external use only. Avoid contact with the eyes. Some users may experience a mild skin irritation. If skin irritation becomes severe, stop use and consult a physician. Do not use on children under 12 years of age unless directed by a physician. If swallowed, get medical help or contact a Poison Control Center right away.
INACTIVE INGREDIENTS
Ascorbic Acid, Ascorbyl Palmitate, Caprylic/Capric Triglyceride, Caprylyl Methicone, Cetyl PEG/PPG-10/1 Dimethicone, Dimethicone, Dimethicone Crosspolymer, Ethoxydiglycol, Helianthus Annuus (Sunflower) Seed Oil, Oleyl Alcohol, Plukenetia Volubilis Seed Oil, Retinyl Palmitate, Rosmarinus Officinalis (Rosemary) Leaf Extract, Squalane, Tocopherol, Tocopheryl Acetate, Zanthoxylum Bungeanum Fruit Extract.
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
PRINCIPAL DISPLAY PANEL - 81 mL Bottle Carton
INGREDIENTS AND APPEARANCE
| ZO SKIN HEALTH PIGMENT CONTROL PLUS BRIGHTENING CREME HYDROQUINONE PLUS VITAMIN C
hydroquinone emulsion |
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| Labeler - ZO Skin Health, Inc. (826468527) |