Label: CARING HANDS- benzalkonium chloride liquid
- NDC Code(s): 82985-002-01, 82985-002-02
- Packager: AXM Premium Cleaning Services, L.P.
- 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 March 16, 2023
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- Active ingredient
- Purpose
- Uses
- Warning
- Direction
- KEEP OUT OF REACH OF CHILDREN
- Other information
- Inactive ingredient
- Product label
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INGREDIENTS AND APPEARANCE
CARING HANDS
benzalkonium chloride liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:82985-002 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE 0.125 g in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) HYALURONIC ACID (UNII: S270N0TRQY) PROPANEDIOL (UNII: 5965N8W85T) METHYLCELLULOSE, UNSPECIFIED (UNII: Z944H5SN0H) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:82985-002-01 1 in 1 BOX 04/10/2023 1 200 mL in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:82985-002-02 1 in 1 BOX 04/10/2023 2 473 mL in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 09/10/2022 Labeler - AXM Premium Cleaning Services, L.P. (118776909) Establishment Name Address ID/FEI Business Operations PreMark Health Science, Inc. 004039083 manufacture(82985-002)
