FDA Label for Topcare Cold And Hot Pain Relieving Analgesic
View Indications, Usage & Precautions
Topcare Cold And Hot Pain Relieving Analgesic Product Label
The following document was submitted to the FDA by the labeler of this product Topco Associates, Llc. 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.
Other
Drug Facts
DISTRIBUTED BY TOPCO ASSOCIATES LLC
ELK GROVE VILLAGE, IL 60007
Otc - Purpose
| Active ingredients | Purpose |
|---|---|
| Lidocaine HCl 4% | Topical analgesic |
| Menthol 1% | Topical analgesic |
Use
temporarily relieves minor pain
Warnings
For external use only
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
When Using This Product
◆ use only as directed. Read and follow all directions and warnings on this carton◆ 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 with a medicated patch◆ avoid contact with eyes and mucous membranes◆ a transient burning sensation may occur upon application but generally disappears in several days
Discontinue Use And Consult 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. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) immediately.
Directions
Adults and children over 12 years:
◆ Apply to affected area not more than 3 to 4 times daily◆ AFTER APPLYING, WASH HANDS WITH SOAP AND WATER
children under 12 years or younger: ask a doctor
Other Information
store at room temperature
Inactive Ingredients
acrylates/C10-30 alkyl Acrylate crosspolymer, alcohol denat., aloe barbadensis leaf juice, aminomethyl propanol, C30-45 alkyl cetearyl dimethicone crosspolymer, caprylyl methicone, cetearyl alcohol, ceteth-20 phosphate, dicetyl phosphate, dimethicone, disodium EDTA, ethylhexylglycerin, glyceryl stearate, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, isohexadecane, phenoxyethanol, polysorbate 60, steareth-21, water.
Questions Or Comments?
1-888-423-0139
Principal Display Panel - 77 G Bottle Carton
TopCare®
health
COMPARE TO ICY HOT® ACTIVE INGREDIENTS*
MAXIMUM STRENGTH LIDOCAINE
Cold & Hot
Pain Relieving
Lidocaine Cream
4% Lidocaine • 1% Menthol
LIDOCAINE 4% / TOPICAL ANALGESIC
MENTHOL 1% / TOPICAL ANALGESIC
- Helps to Numb Away Pain
- Non-Greasy
- Maximum Strength External
Analgesic with 4% Lidocaine
NET WT 2.7 OZ (77 g)
* Please review the disclaimer below.