SUMMERS EVE ACTIVE CHAFE- dimethicone gel 
C.B. Fleet Company, Inc.

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.

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Summers Eve Active Chafe Gel

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)

PRINCIPAL DISPLAY PANEL Summer’s Eve Active Chafe Gel Dimethicone 1.2%/Skin Protectant Net Wt. 1.5 oz (42g)

SUMMERS EVE ACTIVE CHAFE 
dimethicone gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0132-8744
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE12 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
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
ColorWHITEScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0132-8744-421 in 1 CARTON01/12/2021
142 g in 1 JAR; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34701/12/2021
Labeler - C.B. Fleet Company, Inc. (003119054)

Revised: 3/2021
Document Id: f7005aae-bd72-43e2-b633-33eb2225507f
Set id: 00dd1420-977e-431b-a876-7dd2850e6841
Version: 1
Effective Time: 20210308
 
C.B. Fleet Company, Inc.