TOUCHLESS CARE ZINC OXIDE PROTECTANT- touchless care zinc oxide protectant 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 ZINC OXIDE PROTECTANT SPRAY

Active Ingredients

Zinc Oxide 25%

Dimethicone 20%

Purpose

Skin Protectant

Uses

Helps treat and prevent diaper rash associated with incontinence - associated 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

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 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 59º F - 87º F (15º C - 30º C)

Inactive Ingredients

Cyclomethicone, Hexamethyldisiloxane, Lanolin, Light Mineral Oil, Microcrystalline Wax, Vitamin A Palmitate, Vitamin D3, White Petrolatum

Package Label

samples

Sample card

TOUCHLESS CARE ZINC OXIDE PROTECTANT
touchless care zinc oxide protectant spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:69502-504
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	25 g in 100 g
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	20 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
LANOLIN (UNII: 7EV65EAW6H)
MINERAL OIL (UNII: T5L8T28FGP)
CHOLECALCIFEROL (UNII: 1C6V77QF41)
PETROLATUM (UNII: 4T6H12BN9U)
.ALPHA.-TOCOPHEROL, DL- (UNII: 7QWA1RIO01)
CORN OIL (UNII: 8470G57WFM)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
HEXAMETHYLDISILOXANE (UNII: D7M4659BPU)
CYCLOMETHICONE (UNII: NMQ347994Z)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:69502-504-03	3 g in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	04/14/2016

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part347	04/14/2016

Labeler - Crawford Healthcare, Inc. (042813710)

Name	Address	ID/FEI	Business Operations
Establishment
Cosmetic Creations, Inc.		079375497	manufacture(69502-504) , pack(69502-504) , label(69502-504)