CHAMP- alcohol gel 
Champ Products, Ltd

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

Ethyl Alcohol 70%

Purpose

Antiseptic

Uses

Hand Sanitizer to help reduce bacteria that potentially can cause disease.

Directions

Apply liberally to front and back of hands. Allow to dry. Recommended for repeated use.

Warnings

For external use only: hands.

Flammable, keep away from fire or flame.

When using this product avoid contact with the eyes. In case of contact, Rinse eyes thoroughly with water.

Stop use and ask a doctor if irritation or redness appears and lasts.

If swallowed, get medical help or contact a Poison Control Center immediately.

Do not use: in children less than 2 months of age and on open wounds. Do not inhale or ingest.

Supervise children under 6 years of age when using the product to avoid swallowing.

Other information

Store between 00C (320F) – 410C (1050F)

Inactive ingredients

Glycerin, Hydrogen Peroxide, Distilled Water, Polymer, Fragrance.

Customer service

1-833-SANITIZE

Package Label - Principal Display Panel

Label

CHAMP 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78658-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
HYDROGEN PEROXIDE (UNII: BBX060AN9V)  
GLYCERIN (UNII: PDC6A3C0OX)  
GUARAPROLOSE (3500 MPA.S AT 1%) (UNII: 3A1I7376TC)  
FRAGRANCE LAVENDER & CHIA F-153480 (UNII: SXS9CO2TZK)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:78658-001-0130 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/24/2020
2NDC:78658-001-0259 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/24/2020
3NDC:78658-001-03104 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/24/2020
4NDC:78658-001-04118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/24/2020
5NDC:78658-001-05177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/24/2020
6NDC:78658-001-06236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/24/2020
7NDC:78658-001-07296 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/24/2020
8NDC:78658-001-08473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/24/2020
9NDC:78658-001-091000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/24/2020
10NDC:78658-001-103785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/24/2020
11NDC:78658-001-11208198 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/24/2020
12NDC:78658-001-121040990 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/24/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A05/24/2020
Labeler - Champ Products, Ltd (117509904)
Establishment
NameAddressID/FEIBusiness Operations
Aegle Nutrition LLC079354415manufacture(78658-001)

Revised: 5/2020
Document Id: 6ff97ece-90df-4e1f-a488-894ed9d34ee3
Set id: f7d9d723-e821-4d1b-a22a-9d7023029f0f
Version: 1
Effective Time: 20200508
 
Champ Products, Ltd