Astringent
FDA Label NDC 35192-005

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Ca-botana International for the product Astringent (NDC 35192-005). 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 warnings, dosage & administration, inactive ingredient, otc - purpose, otc - active ingredient, otc - keep out of reach of children, indications & usage, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Warnings

For external use only. Avoid contact with eyes. Keep out of reach of children. Do not apply to open wounds. STOP USE AND ask a doctor if condition worsens or symptoms persist for more than seven days, discontinue use of the product.

Dosage & Administration

Adults and children two years of age and older, apply to affected area not more than three times daily or as directed by a doctor. Consult a physician for children under the age of two.

Inactive Ingredient

Butylene Glycol,
Caprylyl Glycol,
Dehydroacetic Acid,
Ethylhexylglycerin,
Glycine,
Hexylene Glycol,
Malic Acid,
Phenoxyethanol,
Purified Water,
Strontium Chloride Hexahydrate,
Xanthan Gum.

Otc - Purpose

Astringent

Otc - Active Ingredient

  • Aluminium acetate

Otc - Keep Out Of Reach Of Children

For external use only.
Avoid contact with eyes.
Keep out of reach of children.
Do not apply to open wounds.
STOP USE AND ask a doctor if condition worsens or
symptoms persist for more than seven days, discontinue
use of the product.

Indications & Usage

  • Adults and children two years of age and older, apply to affected area not more than three times daily or as directed by a doctor. Consult a physician for children under the age of two.

Package Label.Principal Display Panel

Image Of Label (Image1)

Image Of Label (Image1)

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