Label: PHARMA HEALTH- hand sanitizer gel gel
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Contains inactivated NDC Code(s)
NDC Code(s): 79040-111-11, 79040-111-12, 79040-111-13, 79040-111-14, view more79040-111-15, 79040-111-16, 79040-111-17 - Packager: Pharma Health LLC
- 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 October 16, 2020
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredient(s)
- Purpose
- Use
- Warnings
- Do not use
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WHEN USING
When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly 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 or contact a Poison Control Center right away. - STOP USE
- KEEP OUT OF REACH OF CHILDREN
- Directions
- Other information
- Inactive ingredients
- Package Label - Principal Display Panel
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INGREDIENTS AND APPEARANCE
PHARMA HEALTH
hand sanitizer gel gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:79040-111 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 75 mL in 100 mL Inactive Ingredients Ingredient Name Strength CARBOMER 940 (UNII: 4Q93RCW27E) CUPRIC BIS(TRIETHANOLAMINE) (UNII: YBM44X0B6H) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:79040-111-11 118 mL in 1 BOTTLE; Type 0: Not a Combination Product 09/23/2020 2 NDC:79040-111-12 946 mL in 1 BOTTLE; Type 0: Not a Combination Product 09/23/2020 3 NDC:79040-111-13 3785 mL in 1 BOTTLE; Type 0: Not a Combination Product 09/23/2020 4 NDC:79040-111-14 40 mL in 1 BOTTLE; Type 0: Not a Combination Product 09/23/2020 5 NDC:79040-111-15 500 mL in 1 BOTTLE; Type 0: Not a Combination Product 09/23/2020 6 NDC:79040-111-16 1000 mL in 1 BOTTLE; Type 0: Not a Combination Product 09/23/2020 7 NDC:79040-111-17 236 mL in 1 BOTTLE; Type 0: Not a Combination Product 09/23/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 09/23/2020 Labeler - Pharma Health LLC (117551722) Establishment Name Address ID/FEI Business Operations Pharma Health LLC 117551722 manufacture(79040-111)