Active Ingredient
ketoconazole 0.5%
The following Structured Product Label (SPL) was submitted to the FDA by Changsha Beiliang E-commerce Co., Ltd for the product Pureskin Scalp Protection Anti Dandruff Shampoo. (NDC 83887-004). 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 ingredient, purpose, use, warnings, do not use, when using, stop use, ask doctor, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
ketoconazole 0.5%
dandruff
controls flaking, scaling and itching associated with dandruff.
For external use only.
on damaged or inflamed scalp.
if you are pregnant or breast feeding.
on children under 12 years old.
avoid contact with eyes. If product gets into eyes, rinse thoroughly with water.
Keep out of the reach of young children.
No improvement after 4 weeks of normal usage.
irritation or rash occurs.
condition worsens or does not improve in 2-4 weeks.
Keep out of reach of children.
If swallowed, get medical help or contact a Poison Control Center immediately.
Wet hair thoroughly.
Apply shampoo, gently lather and massage for 2 minutes, Rinse thoroughly.
Use 2-3 times per week for up to 8 weeks or as directed by a doctor
Store at 20°C to 25°C (68°F - 77°F)
Aqua
Glycerin
Sodium Cocoyl Isethionate
Propylene Glycol
Aloe Vera
Citric Acid
Rosemary
Tea Tree Oil
Witch Hazel
Chinese Mugwort Leaf
Licorice
Ethylhexylglycerin
Purslane
Sodium Chloride
Serine
Arginine
Coconut Oil
Peppermint
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www.pureskinsupport.com
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