TOUCHLESS CARE ZINC OXIDE PROTECTANT spray

Touchless Care ZINC OXIDE PROTECTANT by

Drug Labeling and Warnings

Touchless Care ZINC OXIDE PROTECTANT by is a Otc medication manufactured, distributed, or labeled by Crawford Healthcare, Inc., Cosmetic Creations, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Zinc Oxide 25%

Dimethicone 20%

Purpose

Skin Protectant

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

Sample card

INGREDIENTS AND APPEARANCE

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
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

Inactive Ingredients
Ingredient Name	Strength
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)

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

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

Labeler - Crawford Healthcare, Inc. (042813710)

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