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NDC 42851-0036-30 ZO Skin Health Pigment Control Plus Blending Creme Hydroquinone 0.04 g/mL Details
ZO Skin Health Pigment Control Plus Blending Creme Hydroquinone 0.04 g/mL
ZO Skin Health Pigment Control Plus Blending Creme Hydroquinone 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 | 42851-0036 |
|---|---|
| Product ID | 42851-036_dd473419-8217-5f56-e053-2995a90ad156 |
| 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 Blending Creme Hydroquinone |
| 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 | g/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 42851-0036-30 (42851003630)
| NDC Package Code | 42851-036-30 |
|---|---|
| Billing NDC | 42851003630 |
| Package | 1 BOTTLE, PLASTIC in 1 CARTON (42851-036-30) / 30 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 c29cbc80-cb97-42d0-b796-ee487b0e85c5 Details
SPL UNCLASSIFIED SECTION
DOSAGE AND ADMINISTRATION
WARNINGS
Keep out of reach of children. Contains Sodium Metabisulfite, a sulfite that may cause serious allergic-type reactions, including anaphylactic symptoms (e.g., hives, itching) and life-threatening or less-severe asthmatic episodes in certain susceptible persons. 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, Beta-Glucan, Caprylyl Glycol, Cetyl Alcohol, Chlorphenesin, Dioscorea Villosa (Wild Yam) Root Extract, Disodium EDTA, Ethylhexyl Palmitate, Glycerin, Glycolic Acid, Palmitic Acid, Phenoxyethanol, Phenyl Trimethicone, Quillaja Saponaria Bark Extract, Smilax Aristolochiifolia Root Extract, Sodium Hydroxide, Sodium Lauryl Sulfate, Sodium Metabisulfite, Sodium Sulfite, Stearyl Alcohol, Tocopheryl Acetate, Water, Yucca Schidigera Root Extract.
SPL UNCLASSIFIED SECTION
PRINCIPAL DISPLAY PANEL - 80 mL Bottle Carton
INGREDIENTS AND APPEARANCE
| ZO SKIN HEALTH PIGMENT CONTROL PLUS BLENDING CREME HYDROQUINONE
hydroquinone emulsion |
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| Labeler - ZO Skin Health, Inc. (826468527) |