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 Apex International Mfg., 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, dimethicone, dimethicone/vinyl dimethicone crosspolymer, silica dimethyl silylate, vinyl dimethicone/methicone silsesquioxane crosspolymer 

Questions?

1-877-666-4782 Monistat.com

PRINCIPAL DISPLAY PANEL

MONISTAT
Care®
Chafing Relief
Powder Gel®
Dimethicone/Skin Protectant
Dimeticona / Protector Para La Piel
NET WT / PESA NETO 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: 57501-087
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 5 (UNII: 0THT5PCI0R)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)
VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER (UNII: 9NH1UDD2RR)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 57501-087-01	1 in 1 CARTON	01/08/2024
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 Drug	M016	01/08/2024

Labeler - Apex International Mfg., LLC (015226132)

Establishment
Name	Address	ID/FEI	Business Operations
Apex International Mfg., LLC		015226132	label(57501-087) , manufacture(57501-087) , pack(57501-087)