Clear Itch Relief
FDA Label NDC 36800-874
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Topcare for the product Clear Itch Relief (NDC 36800-874). 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 purpose, uses, warnings, when using this product, stop use and ask a doctor if, keep out of reach of children, directions, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Uses
- Temporarily relieves pain and itching asociated with:
- rashes due to poison ivy, poison oak or poison sumac.
- insect bites.
- minor skin irritation.
- minor cuts.
- dries the oozing and weeping of poison ivy, poison oak and poison sumac.
Warnings
For external use only.
Flammable: Do not use near heat, flame, or while smoking.
When Using This Product
- keep out of eyes. Rinse with water to remove.
- Do not puncture or incinerate. Contents under pressure. Do no store at temperatures above 120F.
Stop Use And Ask A Doctor If
- condition worsens or does not improve within 7 days.
- symptoms persist for more than 7 days or clear up and occur again with in a few days.
Keep Out Of Reach Of Children
If swallowed, get medical help or contact a Poison Control Center right away.
Directions
- shake well before use.
- adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily.
- children under 2 years of age: ask a doctor.
Inactive Ingredients
Avena Sativa (Oat) Meal Extract,
Camphor, Citric Acid, Diazolidinyl Urea, Fragrance, Glycerin,
Hydroxypropyl Methylcellulose, Methylparaben, Polysorbate 40,
Propylene Glycol, Propylparaben, SD Alcohol 38-B, Sodium Citrate, Water.
CLEAR SKIN PROTECTANT
Pramoxine HCl 1% - Topical Analgesic
Zinc Acetate 0.1% - Skin Protectant
Drying Action PLUS Itch Relief
Continuous Spray
Relieves Pain And Itch
Associated Wit
* Please review the disclaimer below.