FDA Label for Electrum Numb Anesthetic
View Indications, Usage & Precautions
- OTC - ACTIVE INGREDIENT
- OTC - PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- OTC - DO NOT USE
- OTC - WHEN USING
- OTC - STOP USE
- OTC - PREGNANCY OR BREAST FEEDING
- OTC - KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- INACTIVE INGREDIENT
- STORAGE AND HANDLING
- OTC - QUESTIONS
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Electrum Numb Anesthetic Product Label
The following document was submitted to the FDA by the labeler of this product Renu Laboratories, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Otc - Active Ingredient
Active Ingredient
Lidocaine HCl 4%
Otc - Purpose
Purpose
Topical Anesthetic
Indications & Usage
Uses
For the temporary relief of pain associated with minor skin procedures
Warnings
Warnings
For external use only
Otc - Do Not Use
Do Not Use
- on large areas of the body or on cut, irritated or swollen skin
- on puncture wounds
- for more than one week without consulting a doctor
Otc - When Using
When using this product
- Use only as directed. Read and follow all directions and warnings on this label.
- rare cases of serious burns have been reported with products of this type
- do not bandage or apply local heat (such as heating pads) to the area of use or use with a medicated patch
- avoid contact with eyes and mucous membranes
- a transient burning sensation may occur upon applicator but generally disappears in several days
Otc - Stop Use
Stop use and ask a doctor if
- Condition worsens
- redness is present
- irritation develops
- symptoms persist for more than 7 days or clear up and occur again within a few days
- you experience signs of skin injury, such as pain, swelling, or blistering where the product was applied
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 and pets
- If swallowed, get medical help or contact a poison control center right away
Dosage & Administration
Directions
adults and children over 12 years:
- apply a thin layer to affected area every 6 to 8 hours, not to exceed 3 applications in a 24 hour period
- after applying, wash hands with soap and water
- children 12 years or younger - ask a doctor
Inactive Ingredient
Inactive Ingredients: Aloe Barbadensis Leaf Powder, Benzyl Alcohol, Deionized Water, Disodium EDTA, Ethyl Alcohol SD 40B, Glycerin
Storage And Handling
Other Information:
Store at 20-25° C (68 - 77°F)
Otc - Questions
Questions?
574-975-3632
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