Rash Relief Antibacterial: Package Insert and Label Information

RASH RELIEF ANTIBACTERIAL — bacitracin, dimethicone and zinc oxide liquid
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

Bacitracin 500 units/g

Dimethicone 20%

Petrolatum 25%

Purpose

Antibacterial / Skin Protectant

Warnings

Do not use over deep or puncture wounds, infections, or lacerations. Do not apply over large areas of the body.

When using this product do not get into eyes. If contact occurs, rinse eyes thoroughly with water. For external use only.

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

Directions

– Cleanse the 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 to soothe and protect irritated skin.

Inactive Ingredients

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

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

Uses: First aid to help prevent infection in minor cuts, scrapes, and burns. Treats and prevents minor skin irritation: itching, diaper rash, feeding tube sites, cuts, and minor burns.

RRABSPRAY
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RASH RELIEF ANTIBACTERIAL
bacitracin dimethicone zinc oxide liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:15071-672
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Bacitracin (Bacitracin) Bacitracin 500 [iU] in 1 g
Dimethicone (Dimethicone) Dimethicone 20 g in 100 g
Zinc Oxide (Zinc Oxide) Zinc Oxide 25 g in 100 g
Inactive Ingredients
Ingredient Name Strength
Cyclomethicone
Mineral Oil
Lanolin
Microcrystalline Wax
Hexamethyldisiloxane
Water
Cholecalciferol
Vitamin a palmitate
Petrolatum
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:15071-672-11 28 g in 1 BOTTLE None
2 NDC:15071-672-22 44 g in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part333B 06/14/2006
Labeler — Touchless Care Concepts LLC (083459334)
Registrant — Touchless Care Concepts LLC (083459334)

Revised: 11/2011 Touchless Care Concepts LLC

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