Premierpro Flushable Wipes With Dimethicone
FDA Label NDC 61312-010

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Hangzhou Guoguang Touring Commodity Co., Ltd. for the product Premierpro Flushable Wipes With Dimethicone (NDC 61312-010). 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 drug facts, active ingredient, purpose, uses:, warnings:, stop use, keep out of reach of children, do not use:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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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