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Drug Facts
Anti Itch Cream
FDA Label NDC 67234-008
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Natureplex Llc for the product Anti Itch (NDC 67234-008). 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, otc - purpose, use, warnings, do not use, stop use and ask a doctor if, otc - pregnancy or breast feeding, 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 - Purpose
| Active ingredients | Purpose |
|---|---|
| Menthol 1% | Topical Analgesic |
| Pramoxine hydrochloride 1% | Topical Analgesic |
Use
For temporary relief of pain and itching associated with minor skin irritations, minor burns, minor cuts, sunburns, scrapes, insect bites, and rashes due to poison ivy, poison oak, or poison sumac
Warnings
For external use only.
Avoid contact with eyes and nose.
Not for prolonged use.
Do Not Use
- on large areas of the body
Stop Use And Ask A Doctor If
- condition worsens
- symptoms persist for more than 7 days or clear up and occur again within a few days
- redness, irritation, swelling, or pain develops, persists, or increases
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
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: 800-222-1222.
Directions
- adults and children 2 years old and older: apply to affected area not more than 3 to 4 times daily
- children under 2 years old: ask a doctor
Other Information
- store at 15 to 30° C (59 to 86° F)
- Tamper Evident: DO NOT USE IF SEAL ON TUBE IS BROKEN OR MISSING.
Inactive Ingredients
aloe barbadensis leaf juice, carbomer, cetearyl alcohol, DMDM hydantoin, glycerin, polysorbate 60, propylene glycol, purified water, triethanolamine
Questions Or Comments?
866-323-0107 or www.natureplex.com
Principal Display Panel - 42.5 G Tube Box
Natureplex™
MAXIMUM RELIEF
Medicated
Anti-Itch Cream
NET WT. 1.5 Oz. (42.5g)
Principal Display Panel (42.5 g Tube Box)
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