New Wave Hand Sanitizer Gel by BRENNTAG MID-SOUTH, INC.

New Wave Hand Sanitizer Gel by

Drug Labeling and Warnings

New Wave Hand Sanitizer Gel by is a Otc medication manufactured, distributed, or labeled by BRENNTAG MID-SOUTH, INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

NEW WAVE HAND SANITIZER GEL- alcohol gel 
BRENNTAG MID-SOUTH, 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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Active Ingredient(s)

Active Ingredient Alcohol 70% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Use

Hand Sanitizer to help reduce bacteria on the skin.

Warnings

For external use only. Flammable. Keep away from heat or flame

Do not use

  • in children less than 2 months of age
  • on open skin wounds

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • Place enough product on hands to cover all surfaces. Rub hands together until dry.
  • Supervise children under 6 years of age when using this product to avoid swallowing.

Other information

  • Store between 15-30C (59-86F)
  • Avoid freezing and excessive heat above 40C (104F)

Inactive ingredients

Inactive Ingredients: Water, Acrylates/Vinyl Isodecanoate Crosspolymer (10000 MPA.S Neutralized at 0.5%), Aloe Vera Leaf Extract, Isopropyl Myristate, Propylene Glycol, Fragrance, Vitamin E Acetate, Yellow 10, Yellow 5, Blue 1

Product Name

NEW WAVE HAND SANITIZER GEL

NEW WAVE HAND SANITIZER GEL 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 65353-8442
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 L  in 100 L
Inactive Ingredients
Ingredient NameStrength
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
ALOE (UNII: V5VD430YW9)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
ACRYLATES/VINYL ISODECANOATE CROSSPOLYMER (10000 MPA.S NEUTRALIZED AT 0.5%) (UNII: 2N8MDB79NA)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
WATER (UNII: 059QF0KO0R)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 65353-8442-11032 L in 1 TANK; Type 0: Not a Combination Product10/19/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A10/19/202001/31/2025
Labeler - BRENNTAG MID-SOUTH, INC. (122625064)

Revised: 9/2023
Document Id: 06309db0-da3a-b4ca-e063-6394a90a2c46
Set id: b1031ef4-045c-3c99-e053-2a95a90a8410
Version: 11
Effective Time: 20230925