61312-010 Premierpro Flushable Wipes With Dimethicone

61312-010 Premierpro Flushable Wipes With Dimethicone
SPL v7
SPL
SPL Set ID 3af8e562-97b4-46c8-a4a6-8105d7d708c2
Route
TOPICAL
Published
Effective Date 2017-07-13
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dimethicone (32 mg)
Inactive Ingredients
Water Glycerin Propylene Glycol Polysorbate 20 Allantoin Chlorphenesin Decyl Glucoside Sodium Citrate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2017-07-13

Description

Dimethicone  3.2%

Purpose

Skin Protectant


Medication Information

Purpose

Skin Protectant

Description

Dimethicone  3.2%

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.

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.

Warnings:

For external use only.

  • Avoid contact with the eyes​
Drug Facts

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.

Do Not Use:

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

Active Ingredient

Dimethicone  3.2%

Package Labeling:

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

Keep Out of Reach of Children

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


Structured Label Content

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.

Purpose

Skin Protectant

Stop Use (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.

Warnings:

For external use only.

  • Avoid contact with the eyes​
Drug Facts

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.

Do Not Use: (Do not use:)

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

Active Ingredient

Dimethicone  3.2%

Package Labeling:

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

Keep Out of Reach of Children (Keep out of reach of children)

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


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)