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

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

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Active ingredient:
Zinc Oxide 25%, Dimethicone 20%
Available from:
Crawford Healthcare, Inc.
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
Skin Protectant Skin Protectant - 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 condition worsens or symptoms last more than 7 days or clear up and occur again within a few days.
Authorization status:
OTC monograph final
Authorization number:
69502-004-28, 69502-004-57

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%

Purpos e

Skin Protectant

Skin Protectant

Us es

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, or animal bites. 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, Microcystalline Wax, Vitamin A

Palmitate, Vitamin D3, White Petrolatum

Palmitate, Vitamin D3, White Petrolatum

Package Label

Touchless Care

ZINC OXIDE

PROTECTANT SPRAY

Soothes & Protects Irritated,

Denuded Skin

25% Zinc Oxide

No-rub application

CHG Compatible

Crawford

HEALTHCARE

NET WT. 4.5OZ (128g)

Package Label

TOUCHLESS CARE ZINC OXIDE PROTECTANT

touchless care zinc oxide protectant spray

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:6 9 50 2-0 0 4

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

20 g in 10 0 g

ZINC O XIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)

ZINC OXIDE

25 g in 10 0 g

Inactive Ingredients

Ingredient Name

Stre ng th

CYCLO METHICO NE (UNII: NMQ3479 9 4Z)

HEXAMETHYLDISILO XANE (UNII: D7M46 59 BPU)

LANO LIN (UNII: 7EV6 5EAW6 H)

MINERAL O IL (UNII: T5L8 T28 FGP)

MICRO CRYSTALLINE WAX (UNII: XOF59 7Q3KY)

PETRO LATUM (UNII: 4T6 H12BN9 U)

VITAMIN A PALMITATE (UNII: 1D1K0 N0 VVC)

CHO LECALCIFERO L (UNII: 1C6 V77QF41)

.ALPHA.-TO CO PHERO L, DL- (UNII: 7QWA1RIO0 1)

Crawford Healthcare, Inc.

CO RN O IL (UNII: 8 470 G57WFM)

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End

Date

1

NDC:6 9 50 2-0 0 4-

128 g in 1 BOTTLE, SPRAY; Type 0 : No t a Co mbinatio n

Pro duc t

12/0 4/20 15

2

NDC:6 9 50 2-0 0 4-

57 g in 1 BOTTLE, SPRAY; Type 0 : No t a Co mbinatio n

Pro duc t

12/0 4/20 15

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph final

pa rt347

12/0 4/20 15

Labeler -

Crawford Healthcare, Inc. (042813710)

Revised: 3/2019

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