Otc - Active Ingredient
Active Ingredients
Lidocaine HCl 5 %
Recovery Numbing Spray
FDA Label NDC 76348-980
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Renu Laboratories, Llc for the product Recovery Numbing (NDC 76348-980). 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 otc - active ingredient, otc - purpose, indications & usage, warnings, otc - stop use, otc - keep out of reach of children, otc - pregnancy or breast feeding, directions:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Purpose
Topical Anesthetic
Indications & Usage
USES: Temporarily relieves pain, itching and burning associated with inflamed hemorrhoidal tissues.
Warnings
WARNINGS: FOR EXTERNAL USE ONLY
Otc - Stop Use
Stop and ask a doctor if an allergic reaction or rectal bleeding occurs; redness, irritation, swelling, pain or other symptoms begin or increase; condition worsens or does not improve within 7 days.
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. If pregnant or breast-feeding, ask a health professional before use.
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Directions:
Adults and children 12 years and older: When practical, clean area with mild soap and warm water and rinse thoroughly. Gently pat or blot dry with a clean tissue or soft cloth before applying. Apply to the affected area up to 6 times a day.
Children under 12 years of age: Consult a doctor.
Other Safety Information
Other information: Store between 14C - 25C (58F - 77F). Avoid freezing, excessive heat or direct sunlight.
Inactive Ingredient
Inactive Ingredients: Aloe Barbadensis Leaf Powder, Benzyl Alcohol, Deionized Water, Disodium EDTA, Ethyl Alcohol SD 40B, Glycerin
Statement Of Identity
RECOVERY
NUMBING SPRAY
FAST-ACTING TOPICAL
ANESTHETIC WITH ALOE
NET WT 4 FL OZ (118 mL)
NDC 76348-585-04
Otc - When Using
When using this product avoid contact with eyes
Rinse with water to remove
Do not use in large quantities particularl over raw skin or blistered areas
Package Label.Principal Display Panel
PRODUCT LABEL
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