Label: GEL SANITIZER- alcohol gel
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Contains inactivated NDC Code(s)
NDC Code(s): 69394-004-01, 69394-004-02 - Packager: AAkron Rule Corporation
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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 July 26, 2022
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- Active Ingredient
- Purpose
- Use
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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 woundsWhen using this product avoid mouth, eyes, and ears. In case of contact with eyes, flush with water.
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 and call Poison Control.
- KEEP OUT OF REACH OF CHILDREN
- Directions
- Other information
- Inactive ingredients
- Product label
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INGREDIENTS AND APPEARANCE
GEL SANITIZER
alcohol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69394-004 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 ALOE VERA LEAF (UNII: ZY81Z83H0X) CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E) D&C GREEN NO. 5 (UNII: 8J6RDU8L9X) D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) WATER (UNII: 059QF0KO0R) TROLAMINE (UNII: 9O3K93S3TK) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69394-004-01 30 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 09/28/2020 2 NDC:69394-004-02 89 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 09/28/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 09/28/2020 Labeler - AAkron Rule Corporation (002434389)