Active Ingredient
Lidocaine HCL 4%
Pain Relieving Cream Lidocaine Cream
FDA Label NDC 69396-139
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Trifecta Pharmaceuticals Usa Llc for the product Pain Relieving Cream Lidocaine (NDC 69396-139). 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, otc - active ingredient, uses, do not use, when using this product, warnings, if pregnant or breast feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Topical Anasthetic
Topical Anesthetic
Otc - Active Ingredient
Benzyl Alcohol 10%
Uses
Temporary Pain Relief
Do Not Use
- On wounds or damaged skin
- In large quantities
- With a heating pad
- if you are allergic to any ingredients of this product
When Using This Product
- Use only as direcgted
- Avoid contact with eyes, mucous membranes or rashes
- Do not bandage tightly
Warnings
For external Use Only
Do not use
- in eyes
- in large quantities
- over raw or blistered areas, or on deep puncture wounds, animal bites, or serious burns
- for more than one week unless directed by a doctor
If Pregnant Or Breast Feeding
Ask a health professional before use
Keep Out Of Reach Of Children
If swallowed, get medical help or contact a Poison Control Center (800-222-1222) right away
Directions
Adults and children over 12 years
- clean and dry affected area
- Apply to affected area not more than 3 to 4 times daily
- ask a doctor
Children 12 years or younger
Stop Use And Ask A Doctor If
- Skin reactions occur, such as rash, itching, redness, irritation, pain, swelling and blistering
- Conditions worsen
- Symptoms persist for more than 7 days
- Symptoms clear up and occur again within a few days
Other Information
- Avoid storing product in direct sunlight
- Protect product from excessive moisture
- Store with lid closed tightly
Inactive Ingredients
Aloe barbadensis leaf juice, aminomethyl propanol, Butylene glycol, carbome interpolymer type A (allyl sucrose crosslinked), Ceteth-10 phosphate, Cetostearyl alcohol, Dihexadecyl phosphate, Dimethicone, Glyceryl 1-stearate, Hydroxyethly acrylate/sodium acryloydimethyl taurate copolymer, maltodextrin, polysorbate 80, SD alcohol, Steareth-21, water
Distributed By
Trifecta Pharmaceuticals USA®
101 NE Third Avenue, Suite 1500
Ft. Lauderdale, FL. 33301 USA
www.trifecta-pharma.com
Questions
Call 1-888-296-9067
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