Health Smart Creamy Cocoa Butter Petroleum
FDA Label NDC 47046-165

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Anicare Pharmaceuticals Pvt. Ltd for the product Health Smart Creamy Cocoa Butter Petroleum (NDC 47046-165). 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, indications & usage, warnings, otc - when using, otc - stop use, otc - do not use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Active Ingredient

Petrolatum  30%

Otc - Purpose

Purpose

Skin Protectant

Indications & Usage

Uses

  • temporarily protects minor; cuts, scrapes or burns.

  • temporarily protects and helps relieve chapped or cracked skin.

  • helps protect from the drying effects of wind and cold weather.

Warnings

Warnings

For external use only.

Otc - When Using

When using this product do not get into eyes.

Otc - Stop Use

Stop use and ask a doctor if

  • condition worsens
  • symptoms last more than 7 days or clear up and occur again within a few days.

Otc - Do Not Use

Do not use on

  • deep puncture wounds
  • animal bites
  • serious burns

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.

Dosage & Administration

Directions

apply as needed.

Inactive Ingredient

Inactive Ingredients

water (aqua), carbopol 940, stearic acid, glyceryl monostearate, mineral oil, cetearyl alcohol, GE125 emulsifying agent, methylparaben, propylparaben, triethanolamine, tocopheryl acetate, fragrance, cocoa butter.

Other

PRINCIPAL DISPLAY PANEL

HEALTH SMART CREAMY COCOA BUTTER PETROLEUM JELLY

NET WT. 4.5 OZ. (128G)

Package Label.Principal Display Panel

Principal Display Panel (Creamy Petroleum Cocoa Butter Jelly)

Principal Display Panel (Creamy Petroleum Cocoa Butter Jelly)

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