Label: BERKLEY JENSEN FOAMING HAND WITH GREEN TEA AND ALOE- benzalkonium chloride liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 68391-105-48 - Packager: BJWC
- 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 23, 2017
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- Active ingredient
- Uses
- Warnings
- Directons
- Other information
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Inactive ingredients
Water (Aqua), Cocamidopropyl Betaine, Polysorbate 20, Fragrance (Parfum), Glycerin, Decyl Glucoside, Hydroxyethylcellulose, Aloe Barbadensis Leaf Juice, Camellia Sinensis Leaf Extract, Propylene Glycol, Polyquaternium-7, Tetrasodium EDTA, Sodium Citrate, Citric Acid, Benzophenone-4, Methylchloroisothiazolinone, Methylisothiazolinone, Blue 1 (CI 42090), Ext. Violet 2 (CI 60730).
- Label Copy
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INGREDIENTS AND APPEARANCE
BERKLEY JENSEN FOAMING HAND WITH GREEN TEA AND ALOE
benzalkonium chloride liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68391-105 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE 1.3 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) POLYSORBATE 20 (UNII: 7T1F30V5YH) GLYCERIN (UNII: PDC6A3C0OX) DECYL GLUCOSIDE (UNII: Z17H97EA6Y) HYPROMELLOSES (UNII: 3NXW29V3WO) ALOE VERA LEAF (UNII: ZY81Z83H0X) GREEN TEA LEAF (UNII: W2ZU1RY8B0) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600000 MW) (UNII: 0L414VCS5Y) EDETATE SODIUM (UNII: MP1J8420LU) SODIUM CITRATE (UNII: 1Q73Q2JULR) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) SULISOBENZONE (UNII: 1W6L629B4K) METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN) METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) EXT. D&C VIOLET NO. 2 (UNII: G5UX3K0728) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68391-105-48 1419 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 01/20/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333E 01/20/2017 Labeler - BJWC (159082692) Registrant - Apollo Health and Beauty Care Inc. (201901209) Establishment Name Address ID/FEI Business Operations Apollo Health and Beauty Care Inc. 201901209 manufacture(68391-105)