Label: CHAMP- alcohol gel
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Contains inactivated NDC Code(s)
NDC Code(s): 78658-001-01, 78658-001-02, 78658-001-03, 78658-001-04, view more78658-001-05, 78658-001-06, 78658-001-07, 78658-001-08, 78658-001-09, 78658-001-10, 78658-001-11, 78658-001-12 - Packager: Champ Products, Ltd
- Category: HUMAN OTC DRUG LABEL
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.
Drug Label Information
Updated May 8, 2020
If you are a healthcare professional or from the pharmaceutical industry please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredient
- Purpose
- Uses
- Directions
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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)
- KEEP OUT OF REACH OF CHILDREN
- Inactive ingredients
- Package Label - Principal Display Panel
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INGREDIENTS AND APPEARANCE
CHAMP
alcohol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:78658-001 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 70 mL in 100 mL Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:78658-001-01 30 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 05/24/2020 2 NDC:78658-001-02 59 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 05/24/2020 3 NDC:78658-001-03 104 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 05/24/2020 4 NDC:78658-001-04 118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 05/24/2020 5 NDC:78658-001-05 177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 05/24/2020 6 NDC:78658-001-06 236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 05/24/2020 7 NDC:78658-001-07 296 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 05/24/2020 8 NDC:78658-001-08 473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 05/24/2020 9 NDC:78658-001-09 1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 05/24/2020 10 NDC:78658-001-10 3785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 05/24/2020 11 NDC:78658-001-11 208198 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 05/24/2020 12 NDC:78658-001-12 1040990 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 05/24/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 05/24/2020 Labeler - Champ Products, Ltd (117509904) Establishment Name Address ID/FEI Business Operations Aegle Nutrition LLC 079354415 manufacture(78658-001)
