SUMMERS EVE ACTIVE CHAFE- dimethicone gel

Summers Eve Active Chafe by

Drug Labeling and Warnings

Summers Eve Active Chafe by is a Otc medication manufactured, distributed, or labeled by C.B. Fleet Company, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

Purpose

Dimethicone 1.2%...................................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 lasts 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

dimethicone, dimethicone/vinyl dimethicone crosspolymer, cyclopentasiloxane, vinyl dimethicone/methicone silsesquioxane crosspolymer, silica dimethyl silylate 

Questions?

866 – 787 – 6383 or  Summerseve.com

PRINCIPAL DISPLAY PANEL

Summer’s Eve Active Chafe Gel

Dimethicone 1.2%/Skin Protectant

Net Wt. 1.5 oz (42g)

INGREDIENTS AND APPEARANCE

SUMMERS EVE ACTIVE CHAFE 
dimethicone gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0132-8744
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	12 mg  in 1 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)

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0132-8744-42	1 in 1 CARTON	01/12/2021
1		42 g in 1 JAR; 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	01/12/2021

Labeler - C.B. Fleet Company, Inc. (003119054)