Otc - Active Ingredient
Salicylic Acid 2 percent
Gold Mountain Beauty Drying
FDA Label NDC 76348-461
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Renu Laboratories, Inc. for the product Gold Mountain Beauty Drying (NDC 76348-461). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, uses, warnings, otc - do not use, dosage & administration, recent major changes, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Topical Acne Treatment
Uses
- for the treatment of acne
- healing and drying acne breakouts
- helps clear acne pimples, blackheads or whiteheads and allows skin to heal
- penetrates pores to control acne blemishes
- helps keep skin clear of new acne pimples
Warnings
Warnings
For external use only
- skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time.
Otc - Do Not Use
Do Not Use
- on broken skin
- on large areas of the skin
- if pregnant or breast-feeding, ask a health professional before use.
Dosage & Administration
Directions
- do not shake
- clean skin thoroughly before applying this product
- carefully place wand or cotton swab into sediment at bottom and apply directly to blemish
- because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a doctor
- if bothersome dryness or peeling occurs, reduce application to once a day or every other day
Recent Major Changes
In Directions only a date was changed
Each section required only a date change
Inactive Ingredient
Camphor, Deionized Water, Hippophae Rhamnoides (Sea Berry) Fruit and Seed Oil, Iron Oxide, Isopropyl Alcohol, Magnesium Aluminum Silicate, Sulfur, Zinc Oxide
Otc - Keep Out Of Reach Of Children
Keep out of reach of children
If swallowed get medical help or contact a Poison Control Center right away
Package Label.Principal Display Panel
LABEL AND BOX ART FOR DRYING LOTION
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