BEAUTY 360 SOOTHING BATH TREATMENT- colloidal oatmeal powder

Beauty 360 Soothing Bath Treatment by

Drug Labeling and Warnings

Beauty 360 Soothing Bath Treatment by is a Otc medication manufactured, distributed, or labeled by Davion, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Colloidal Oatmeal, 100%

Purpose

Skin Protectant

Uses

Temporarily protects and helps relieve minor skin irritation and itching due to one or more of the following:

• Poison ivy, oak or sumac
• Insect bites
• Rashes
• Eczema

Warnings

For external use only.

When using this product

• Do not get into eyes.
• In some skin conditions soaking too long may overdry skin.
• To avoid slipping, use mat in tub or shower.

Stop use and ask a doctor if

• Condition worsens.
• 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 right away.

Directions

• Turn warm water faucet on to full force.
• Slowly sprinkle 1 packet of colloidal oatmeal directly under the faucet into the tub or container.
• Stir any colloidal oatmeal settled on the bottom.
• Soak affected area for 15 - 30 minutes as needed or as directed by a doctor.
• Pat dry (do not rub) to keep a thin layer on the skin.

SPL UNCLASSIFIED SECTION

Distributed by:
CVS Pharmacy, Inc.
One CVS Drive, Woonsocket, RI 02895
1-800-SHOP CVS

PRINCIPAL DISPLAY PANEL - 8 Packet Carton

beauty 360TM

SOOTHING
BATH TREATMENT
100% NATURAL COLLOIDAL
OATMEAL SKIN PROTECTANT

Protects & relieves skin irritation & itching due to:
poison ivy/oak/sumac, rashes, insect bites, eczema,
prickly heat, chicken pox, hives, sunburn
FRAGRANCE FREE

8 single use bath packets
NET WT 12 OZ (340 g) 1.5 OZ (42.5 g) Each

INGREDIENTS AND APPEARANCE

BEAUTY 360 SOOTHING BATH TREATMENT 
colloidal oatmeal powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 42669-230
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Oatmeal (UNII: 8PI54V663Y) (Oatmeal - UNII:8PI54V663Y)	Oatmeal	1000 mg  in 1 g

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42669-230-08	8 in 1 CARTON	09/01/2016
1		42.5 g in 1 PACKET; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part347	09/01/2016

Labeler - Davion, Inc. (174542928)

Registrant - Davion, Inc. (174542928)