Otc - Active Ingredient
Active ingredient Purpose
Lidocaine 4%..................................................................Topical anesthetic
Foster And Thrive Patch
FDA Label NDC 70677-1188
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Strategic Sourcing Services, Llc for the product Foster And Thrive (NDC 70677-1188). 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, warnings, otc - do not use, otc - when using, otc - stop use, 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
Use
temporarily relieves minor pain
Warnings
Warnings
For external use only
Otc - Do Not Use
Do not use
- more than 1 patch on your body at a time
- at the same time as other topical analgesics
- on damaged skin, or puncture wounds
- for more than one week without consulting a doctor
- if you are allergic to any ingredients of this product
Otc - When Using
When using this product
- use only as directed. Read and follow all directions and warnings on this label.
- do not allow contact with the eyes
- do not bandage tightly or apply local heat (such as heating pads) to the area of use
- avoid the patch getting wet for better adhesion
- dispose of used patch in manner that always keeps product away from children or pets. Used patches still contain enough lidocaine to cause serious or life-threating problems.
Otc - Stop Use
Stop use and ask a doctor if
- skin reactions occur, such as pain, swelling, rash, redness, itching, irritation, or blistering where the product was applied
- symptoms persist for more than 7 days or clear up and occur again within a few days
- condition worsens
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 (1-800-222-1222) right away.
Indications & Usage
Directions
- adults and children over 12 years:
- clean and dry affected area
- expose a portion of the patch by firmly grasping an edge or corner and gently pull apart until backing separates
- position and apply exposed portion of the patch to affected area
- once exposed portion of patch is positioned, carefully remove remaining backing to completely apply patch to affected area
- use 1 patch at a time, not more than 3 to 4 times daily
- children under 12 years or younger: ask a doctor
Storage And Handling
Other information
- store at room temperature 20-25°C (68-77°F)
Inactive Ingredient
Inactive ingredients
alcohol, aluminum glycinate, glycerin, kaolin, methylparaben, polysorbate 80, propylparaben, purified water, sodium polyacrylate (2,500,000 MW), tartaric acid, titanium dioxide
Dosage & Administration
Distributed by: Mckesoon Corp., via Strategic Sourcing Services LLC. Memphis, TN 38141
Product of China
* Please review the disclaimer below.
