Label: AMBER AND BLACK- benzalkonium chloride soap
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Contains inactivated NDC Code(s)
NDC Code(s): 73696-104-16 - Packager: NV Labs
- 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 January 13, 2022
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- Active Ingredient
- USES
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WARNING
Warnings
For External Use only
When using this product
Avoid Contact with eyes
In case of contact, rinse eyes thoroughly with water.
Stop use and ask a doctor if irritation orredness develops.
Keep out of reach of children, If swallowed, get medical help or contact a Poison Control Center right away.
- Directions
- In active Ingredients
- Manufactured By: Questions or Comments
- Keep out of Reach of Children
- Purpose
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INGREDIENTS AND APPEARANCE
AMBER AND BLACK
benzalkonium chloride soapProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:73696-104 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE 0.13 g in 100 g Inactive Ingredients Ingredient Name Strength PEG-150 DISTEARATE (UNII: 6F36Q0I0AC) 0.3 g in 100 g FD&C RED NO. 40 (UNII: WZB9127XOA) 2.15 g in 100 g MYRISTAMINE OXIDE (UNII: J086PM3RRT) 3.8 g in 100 g GLYCERIN (UNII: PDC6A3C0OX) 0.5 g in 100 g LAURAMIDOPROPYLAMINE OXIDE (UNII: I6KX160QTV) 4 g in 100 g SODIUM CHLORIDE (UNII: 451W47IQ8X) 1.2 g in 100 g WATER (UNII: 059QF0KO0R) 68.4896 g in 100 g COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) 9 g in 100 g CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP) 0.1 g in 100 g FD&C YELLOW NO. 5 (UNII: I753WB2F1M) 1.4483 g in 100 g DITETRACYCLINE TETRASODIUM EDETATE (UNII: WX0A0IT7K5) 0.05 g in 100 g SODIUM BENZOATE (UNII: OJ245FE5EU) 0.1 g in 100 g LAURAMINE OXIDE (UNII: 4F6FC4MI8W) 11 g in 100 g D&C RED NO. 33 (UNII: 9DBA0SBB0L) 0.33 g in 100 g PEG-120 METHYL GLUCOSE DIOLEATE (UNII: YM0K64F20V) 0.1 g in 100 g ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) 1 g in 100 g Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:73696-104-16 473 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 04/29/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 04/29/2020 Labeler - NV Labs (019662814) Registrant - NV Labs (019662814) Establishment Name Address ID/FEI Business Operations NV Labs 019662814 manufacture(73696-104)
