Label: CHEMBRITE- hand sanitizer gel
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Contains inactivated NDC Code(s)
NDC Code(s): 78036-001-01, 78036-001-02, 78036-001-03, 78036-001-04, view more78036-001-05, 78036-001-06, 78036-001-07, 78036-001-08, 78036-001-09, 78036-001-10, 78036-001-11, 78036-001-12 - Packager: Interion Pte Ltd
- 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 May 28, 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
CHEMBRITE
hand sanitizer gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:78036-001 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL 60 mL in 100 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) CARBOXYMETHYLCELLULOSE (UNII: 05JZI7B19X) WATER (UNII: 059QF0KO0R) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) TROLAMINE (UNII: 9O3K93S3TK) PEG-150 DILAURATE (UNII: CF607I8E19) BENZYL ALCOHOL (UNII: LKG8494WBH) DENATONIUM BENZOATE (UNII: 4YK5Z54AT2) LEMON OIL, TERPENELESS (UNII: X69W83NI7V) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:78036-001-01 200 mL in 1 BOTTLE; Type 0: Not a Combination Product 05/25/2020 2 NDC:78036-001-02 250 mL in 1 BOTTLE; Type 0: Not a Combination Product 05/25/2020 3 NDC:78036-001-03 500 mL in 1 BOTTLE; Type 0: Not a Combination Product 05/25/2020 4 NDC:78036-001-04 1000 mL in 1 BOTTLE; Type 0: Not a Combination Product 05/25/2020 5 NDC:78036-001-05 5000 mL in 1 CONTAINER; Type 0: Not a Combination Product 05/25/2020 6 NDC:78036-001-06 10000 mL in 1 CONTAINER; Type 0: Not a Combination Product 05/25/2020 7 NDC:78036-001-07 20000 mL in 1 CONTAINER; Type 0: Not a Combination Product 05/25/2020 8 NDC:78036-001-08 25000 mL in 1 CONTAINER; Type 0: Not a Combination Product 05/25/2020 9 NDC:78036-001-09 30000 mL in 1 CONTAINER; Type 0: Not a Combination Product 05/25/2020 10 NDC:78036-001-10 200000 mL in 1 CONTAINER; Type 0: Not a Combination Product 05/25/2020 11 NDC:78036-001-11 209000 mL in 1 CONTAINER; Type 0: Not a Combination Product 05/25/2020 12 NDC:78036-001-12 1000000 mL in 1 CONTAINER; Type 0: Not a Combination Product 05/25/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 05/25/2020 Labeler - Interion Pte Ltd (894599711) Establishment Name Address ID/FEI Business Operations Interion Pte Ltd 894599711 manufacture(78036-001)
