MONISTAT COMPLETE CARE CHAFING RELIEF- dimethicone gel

Monistat Complete Care Chafing Relief by

Drug Labeling and Warnings

Monistat Complete Care Chafing Relief by is a Otc medication manufactured, distributed, or labeled by Insight Pharmaceuticals LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Monistat Care Chafing Relief Powder Gel®

Drug Facts

Active ingredient

Dimethicone 1.2%

Purpose

Skin Protectant

Use

• Temporarily protects and helps relieve chafed, chapped or cracked skin.

Warnings

For external use only

Do not use on

• deep or puncture wounds
  
• animal bites
  
• serious burns

When using this product

do not get into eyes

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 (1-800-222-1222) right away.

Directions

Apply as needed

Other information

Store at 20˚-25˚C (68˚-77˚F)

Inactive ingredients

cyclomethicone, decamethyltetrasiloxane, hydrogen dimethicone, silicon dioxide, tocopheryl acetate, trisiloxane

Questions?

1-877-666-4782 Monistat.com

PRINCIPAL DISPLAY PANEL

MONISTAT®
CARE™
Chafing Relief Powder Gel®
DIMETHICONE /SKIN PROTECTANT
NET WT 1.5 OZ. (42g)

INGREDIENTS AND APPEARANCE

MONISTAT COMPLETE CARE CHAFING RELIEF 
dimethicone gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63736-031
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	1.2 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
CYCLOMETHICONE (UNII: NMQ347994Z)
DECAMETHYLTETRASILOXANE (UNII: C23WAL597T)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
TRISILOXANE (UNII: 9G1ZW13R0G)
HYDROGEN DIMETHICONE (20 CST) (UNII: 12Z59IF64N)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63736-031-01	1 in 1 CARTON	11/15/2013
1		42 g in 1 TUBE; 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	11/15/2013

Labeler - Insight Pharmaceuticals LLC (055665422)