INCONTINENCE CARE WIPE- dimethicone swab

United States - English - NLM (National Library of Medicine)

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Active ingredient:
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)
Available from:
Cardinal Health, Inc.
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
- temporarily protects and helps relieve chapped or cracked skin - helps prevent perineal dermatitis  - protects minor skin irritation associated with perineal dermatitis
Authorization status:
OTC monograph not final
Authorization number:
63517-131-22

INCONTINENCE CARE WIPE- dimethicone swab

Cardinal Health, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they

comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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INCONTINENCE CARE WIPE

Drug Facts

Active Ingredient

Dimethicone 3.2%

Purpose

Skin Protectant

Uses

temporarily protects and helps relieve chapped or cracked skin

helps prevent perineal dermatitis

protects minor skin irritation associated with perineal dermatitis

Warnings

For external use only

When using this product

Avoid direct 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 Posion Control Center right away.

Discontinue if irritation or redness develops

Gloves diminish sensitivity to heat

Closely monitor heat level with infants, unresponsive or skin sensitive individuals

Do not use

On deep or puncture wounds

Animal bites

Serious burns

Directions

Tear open pouch 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

Warming 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 200 hours. Discard wipes that have been:

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

Stored longer than 200 hours within the warmer; or

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

Other Information

Store at room temperature.

Inactive Ingredients

Aqua, Glycerin, Cetearyl Alcohol, PPG-15 Stearyl Ether, Glyceryl Stearate, PEG-100 Stearate,

Phenoxyethanol, Aloe Barbadensis Leaf Extract, Caprylyl Glycol, Xanthan Gum

Package Labeling:

INCONTINENCE CARE WIPE

dimethicone swab

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:6 3517-131

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

DIMETHICO NE (UNII: 9 2RU3N3Y1O) (DIMETHICONE - UNII:9 2RU3N3Y1O)

DIMETHICONE

32 mg in 1 g

Inactive Ingredients

Ingredient Name

Stre ng th

WATER (UNII: 0 59 QF0 KO0 R)

Cardinal Health, Inc.

GLYCERIN (UNII: PDC6 A3C0 OX)

CETO STEARYL ALCO HO L (UNII: 2DMT128 M1S)

PPG-15 STEARYL ETHER (UNII: 1II18 XLS1L)

GLYCERYL MO NO STEARATE (UNII: 230 OU9 XXE4)

PEG-10 0 STEARATE (UNII: YD0 1N19 9 9 R)

PHENO XYETHANO L (UNII: HIE49 2ZZ3T)

ALO E VERA LEAF (UNII: ZY8 1Z8 3H0 X)

CAPRYLYL GLYCO L (UNII: 0 0 YIU5438 U)

XANTHAN GUM (UNII: TTV12P4NEE)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:6 3517-131-22

3 in 1 PACKET

0 5/15/20 19

1

1 in 1 POUCH

1

52.9 3 g in 1 PATCH; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph no t final

pa rt356

0 5/15/20 19

Labeler -

Cardinal Health, Inc. (097537435)

Revised: 5/2019

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