Rash Relief: Package Insert and Label Information

RASH RELIEF — zinc oxide and dimethicone spray
Touchless Care Concepts LLC

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.

Active Ingredients

Dimethicone 20%

Zinc Oxide 25%

Purpose

Skin Protectant

Uses: Treats and prevents minor skin irritation — itching — diaper rash — feeding tubes sites, or lacerations.

Warnings

– Do not use over deep or puncture wounds, infections, or lacerations. For external use only.

– When using this product do not get into eyes. If contact occurs, rinse eyes throughout with water.

– Stop use and ask a doctor if condition worsens or does not improve with 7 days.

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- each diaper change with incontinence care- to soothe and protect irritated skin.

Inactive Ingredients

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


Uses: Treats and prevents minor skin irritation — itching — diaper rash — feeding tubes sites, or lacerations.

– Keep out of reach of children. If swallowed, get medical help or contact a local poison control center immediately.


RR25
(click image for full-size original)

RR25
RASH RELIEF
zinc oxide dimethicone spray
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:15071-604
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Zinc Oxide (Zinc Oxide) Zinc Oxide 25 g in 100 g
Dimethicone (Dimethicone) Dimethicone 20 g in 100 g
Inactive Ingredients
Ingredient Name Strength
Mineral Oil
Cyclomethicone
Lanolin
Microcrystalline Wax
Hexamethyldisiloxane
Water
Cholecalciferol
Vitamin A Palmitate
Petrolatum
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:15071-604-11 56 g in 1 BOTTLE, SPRAY None
2 NDC:15071-604-22 128 g in 1 BOTTLE, SPRAY None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part347 06/21/2005
Labeler — Touchless Care Concepts LLC (083459334)
Registrant — Touchless Care Concepts LLC (083459334)

Revised: 10/2011 Touchless Care Concepts LLC

DrugInserts.com provides trustworthy package insert and label information about marketed drugs as submitted by manufacturers to the US Food and Drug Administration. Package information is not reviewed or updated separately by DrugInserts.com. Every individual package label entry contains a unique identifier which can be used to secure further details directly from the US National Institutes of Health and/or the FDA.

As the leading independent provider of trustworthy medication information, we source our database directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. Our material is not intended as a substitute for direct consultation with a qualified health professional.

Terms of Use | Copyright © 2021. All Rights Reserved.