NDC | 59555-601-04, 59555-601-08, 59555-601-10, 59555-601-11 |
Set ID | 09b47215-b7bb-4153-9828-3718dab88a95 |
Category | HUMAN OTC DRUG LABEL |
Packager | R&R Lotion, Inc. |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART333A |
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
Active Ingredients Purpose Benzethonium Chloride 0.2% Antibacterial Dimethicone 2.0% Skin Protectant - Uses
Temporarily prevents, protects, and helps shield the skin from biological and chemical environments while moisturizing your skin. Kills 99.99% of Germs.
Close - Warnings
For external use only
- Keep out of reach of children, except under adult supervision
- If swallowed, get medical help
- Discontinue use if skin irritation or redness develops.
- Directions
Apply to hands & body and rub until lotion is absorbed. Will not dry out your skin or crack your nails like Alcohol Based Sanitizers.
Close - Ingredients
DI Water, Incroquat TMS, Propylene Glycol, Sunflower Butter, Octyl Palmitate, Stearyl Alcohol, Cetyl Alcohol, Geoguard Ultra, Aloe Vera, Jojoba, Blue Agave, Blueberry, Cranberry, Pomegranate, Raspberry, Strawberry, Green Tea, Green Coffee Bean, Grape Seed, Acai Berry, Vitamins A, D, & E
Close - Questions or Comments?
- PRINCIPAL DISPLAY PANEL - 236 mL Bottle Label
- INGREDIENTS AND APPEARANCE
I.C. BARRIER
benzethonium chloride and dimethicone lotion/shampooProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:59555-601 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Benzethonium Chloride (UNII: PH41D05744) (Benzethonium - UNII:1VU15B70BP) Benzethonium Chloride 2 mg in 1 mL Dimethicone (UNII: 92RU3N3Y1O) (Dimethicone - UNII:92RU3N3Y1O) Dimethicone 20 mg in 1 mL Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) Propylene Glycol (UNII: 6DC9Q167V3) Stearyl Alcohol (UNII: 2KR89I4H1Y) cholecalciferol (UNII: 1C6V77QF41) Cetyl Alcohol (UNII: 936JST6JCN) vitamin A (UNII: 81G40H8B0T) .Alpha.-Tocopherol (UNII: H4N855PNZ1) Ethylhexyl Palmitate (UNII: 2865993309) Product Characteristics Color WHITE Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:59555-601-08 237 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 2 NDC:59555-601-04 60 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 3 NDC:59555-601-10 946 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 4 NDC:59555-601-11 3785 mL in 1 BOTTLE, PUMP; 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 09/17/2014 Labeler - R&R Lotion, Inc. (062979000)