Active Ingredients, Purpose
colloidal sulfur 1%
(equivalent to precipitated sulfur 5%)…...acne treatment
Aqua Kavi
FDA Label NDC 42771-0002
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Kavi Skin Solutions, Inc. for the product Aqua Kavi (NDC 42771-0002). 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 active ingredients, purpose, indications & usage, dosage and administration, warnings, inactive ingredients, purpose, keep out of reach of children, active ingredients, uses, warnings, directions, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Indications & Usage
uses
for the treatment and prevention of oily, acne-prone skin
directions
▪ use as a replacement to your existing cleanser(s)
▪ lather using warm water and cleanse affected areas
▪ rinse and pat dry
▪ cleanse once to three times per day
▪ monitor skin for dryness or irritation and reduce application as needed
Dosage And Administration
▪ use as a replacement to your existing cleanser(s)
▪ lather using warm water and cleanse affected areas
▪ rinse and pat dry
▪ cleanse once to three times per day
▪ monitor skin for dryness or irritation and reduce application as needed
Warnings
▪ for external use only
▪ keep out of reach of children
when using this product avoid other antiseborrheics unless otherwise directed by your physician. use in conjunction with other oral or topical anti-acne drugs may increase dryness or irritation of the skin.
Inactive Ingredients
palm and palm kernel oil, vegetable-based moisturizer, glycerin, ethanol, water
Purpose
for the treatment and prevention of oily, acne-prone skin
Keep Out Of Reach Of Children
▪ for external use only
▪ keep out of reach of children
Active Ingredients, Uses, Warnings, Directions, Inactive Ingredients
drug facts
active ingredients/purpose
colloidal sulfur 1%
(equivalent to precipitated sulfur 5%)…...acne treatment
uses
for the treatment and prevention of acne or as a non-inflammatory cleanser on skin diagnosed with eczema, rosacea, psoriasis, or other condition requiring a pH-balancing topical
warnings
▪ for external use only
▪ keep out of reach of children
when using this product avoid other antiseborrheics unless otherwise directed by your physician. use in conjunction with other oral or topical anti-acne drugs may increase dryness or irritation of the skin.
directions
▪ use as a replacement to your existing cleanser(s)
▪ lather using warm water and cleanse affected areas
▪ rinse and pat dry
▪ cleanse once to three times per day
▪ monitor skin for dryness or irritation and reduce application as needed
inactive ingredients
palm and palm kernel oil, vegetable-based moisturizer, glycerin, ethanol, water
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