FDA Label for Premierpro Flushable Wipes With Dimethicone

View Indications, Usage & Precautions

Premierpro Flushable Wipes With Dimethicone Product Label

The following document was submitted to the FDA by the labeler of this product Hangzhou Guoguang Touring Commodity Co., Ltd.. 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.

Drug Facts




Active Ingredient



Dimethicone  3.2%


Purpose



Skin Protectant


Uses:



Helps treat and prevent diaper rash. Protects chafed skin associated with diaper rash and helps protect from wetness. Temporarily protects and helps relieve chapped or cracked skin.


Warnings:



For external use only.

  • Avoid contact with the eyes​

Stop Use



and contact a physician if condition worsens, symptoms last more than 7 days or clear up and occur again within a few days.


Keep Out Of Reach Of Children



If swallowed, get medical help or contact Poison Control Center right away.


Do Not Use:



• On deep or puncture wounds • Animal bites • Serious burns


Directions:



Pull back label and remove wipes

• Thoroughly cleanse soiled area, using one wipe at a time

•Use as often as necessary

•Dispose of cloths in a waste receptacle

•Do not flush

Heating Instructions:

• Wipes may be used at room temperature but if heating is desired, wipes may be warmed in a wipes warmer. Wipes should be warmed:

in a single warming session at temperatures not exceeding 52°C (125°F) and

• for a maximum of 4 days. Discard wipes that have been:

• Exposed to warming temperatures exceeding 52C (125F); or

• Stored longer than 4 days within the warmer; or

• Been warmed, allowed to cool, and then re-warmed.


Other Information:



•When not in a warmer, store between 15-30˚C (59-86˚F)


Inactive Ingredients:



Allantoin, Aqua, 2-Bromo-2-Nitropropane-1, 3-Diol, Chlorphenesin, Decyl Glucoside, Glycerin, Polyaminopropyl Biguanide, Polysorbate 20, Propylene Glycol, Sodium Citrate


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