TOUCHLESS CARE ZINC OXIDE PROTECTANT spray

Country: United States

Language: English

Source: NLM (National Library of Medicine)

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

Summary of Product characteristics

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, 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
Palmitate, Vitamin D3, White Petrolatum
PACKAGE LABEL
SAMPLE CARD
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 2-50 4
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRE NG TH
ZINC O XIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)
ZINC OXIDE
25 g in 10 0 g
DIMETHICO NE (UNII: 9 2RU3N3Y1O) (DIMETHICONE - UNII:9 2RU3N3Y1O)
DIMETHICONE
20 g in 10 0 g
INACTIVE INGREDIENTS
INGREDIENT NAME