Symba Skin Lightening
FDA Label NDC 71607-200

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Craig Doura Llc for the product Symba Skin Lightening (NDC 71607-200). 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 other, active ingredients, purpose, uses, warnings, do not use, when using this product, stop use and consult a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

Active Ingredients

Hydroquinone 1.9%

Purpose

Skin Lightening Agent

Uses

Gradually lightens uneven and dark discoloration. Fades freckles, age, and liver spots. Moisturizes the skin. Leaves skin perfumed, soft, and smooth.

Warnings

For external use only

Do Not Use

  • on irritated or broken skin
  • on children under 12 years old
  • to prevent sunburn
  • in combination with products containing Resorcinol, Phenol, or Salicylic Acid

When Using This Product

  • mild irritation or temporary skin darkening may occur
  • avoid contact with eyes
  • avoid unnecessary sun exposure

Stop Use And Consult A Doctor If

  • darkening persists
  • irritation becomes severe

Otc - Pregnancy Or Breast Feeding

If pregnant or breast feeding, consult a doctor before use.

Otc - Keep Out Of Reach Of Children

KEEP OUT OF REACH OF CHILDREN. If swallowed, call poison control or get medical attention immediately.

Directions

  • for sensitive skin, test overnight on a small section of skin inside the elbow before use
  • apply a thin layer to skin on affected areas
  • use sunscreen to prevent darkening from recurring
  • use twice daily for at least 6 weeks or as directed by doctor

Inactive Ingredients

Water (Aqua), Glyceryl Monostearate, Propylene Glycol, Papaya Extract (Carica Papaya Fruit Extract), Mineral Oil(Paraffinum Liquidum), Cetyl Palmitate, Isopropyl Myristate, Dimethicone, Sodium Lauryl Sulphate, Allantoin, Fragrance (Parfum), Sodium Metabisulfite, Ascorbic Acid (Vitamin C), Propylparaben, Edetate Disodium, FD&C Yellow 5.

Principal Display Panel - 57 G Tube Carton

SYMBA®
SKIN LIGHTENING CREAM
PAPAYA

NDC 71607-200-01

With Papaya Fruit Extract, Vitamin A, and Vitamin E

Principal Display Panel (57 g Tube Carton)

Principal Display Panel (57 g Tube Carton)

* Please review the disclaimer below.