Touchless Care CLEAR PROTECTANT SPRAY

Drug Labeling and Warnings

Drug Details [pdf]

TOUCHLESS CARE CLEAR PROTECTANT- dimethicone spray 
Crawford Healthcare, 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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Touchless Care CLEAR PROTECTANT SPRAY

Active Ingredients

Dimethicone 20%

Purpose

Skin Protectant

Uses

■ Helps treat and prevent diaper rash associated with incontinenceassociated dermatitis.

■ Protects minor skin irritation due to excess moisture, urine or stool.

■ Helps seal out wetness.

Warnings

Do not use on deep puncture wounds, serious burns, animal bites, or broken skin. For external use only. When using this product do not get into eyes. If contact occurs, rinse eyes thoroughly with water.

Stop use and ask a doctor if

if condition worsens or 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 a local poison control center immediately.

Directions

■ Cleanse skin area and allow to dry.

■ Shake bottle well before use.

■ Spray 4 -6 inches from skin. No rub-in is required.

■ Apply liberally as often as necessary.

Other Information

Store at 59° F - 87° F (15° C - 30° C)

Inactive Ingredients

Cyclomethicone, Dimethicone, Hexamethyldisiloxane, Lanolin, Light Mineral Oil, Microcystalline Wax, Vitamin A Palmitate, Vitamin D3, Water, White Petrolatum

Distributed by: Crawford Healthcare, Inc. Doylestown, PA 18901

Touchless Care is a registered trademark of Crawford

Healthcare, Inc. © Copyright Crawford Healthcare Ltd, 2014

www.crawfordhealthcare.com

■ 1-855-522-2211

Made in the USA              Issue 1 - Oct. 2014

Package Label

TOUCHLESS CARE CLEAR PROTECTANT 
dimethicone spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69502-501
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	20 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
CYCLOMETHICONE (UNII: NMQ347994Z)
HEXAMETHYLDISILOXANE (UNII: D7M4659BPU)
LANOLIN (UNII: 7EV65EAW6H)
MINERAL OIL (UNII: T5L8T28FGP)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
WATER (UNII: 059QF0KO0R)
PETROLATUM (UNII: 4T6H12BN9U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69502-501-57	57 g in 1 BOTTLE; Type 0: Not a Combination Product	08/29/2016	09/30/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	12/29/2014	09/30/2019

Labeler - Crawford Healthcare, Inc. (042813710)

Establishment
Name	Address	ID/FEI	Business Operations
Cosmetic Creations Inc.		079375497	manufacture(69502-501)

Revised: 10/2017

Document Id: 5c4fe34e-26ee-260e-e053-2a91aa0ac9d6

34390-5

Set id: 56ba6eff-9e02-482b-8ad9-d5bddfb97f4b

Version: 4

Effective Time: 20171024