Label: CALFARME FOAM CARE- benzalkonium chloride liquid
- NDC Code(s): 70136-101-01, 70136-101-02, 70136-101-04
- Packager: Calfarme (singapore) Pte.Ltd
- Category: HUMAN OTC DRUG LABEL
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 October 19, 2019
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- Official Label (Printer Friendly)
- Drug Facts
- Active Ingredient
- Purpose
- Uses
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Warnings
For external use only.
Flammable: Keep away from fire or flame.
Do not use: ■ full strength. Dilute 1 part to 20 parts with Distilled water (50ml to 1,000ml with Distilled water).
When using this product
■ do not get into eyes
■ if contact occurs, rinse eyes thoroughly with water
■ dilute with distilled water before use because acidic or hard water may render the product inactiveStop use and ask a doctor if
■ irritation or redness develops
■ condition persists for more than 72 hours. - Directions
- INACTIVE INGREDIENT
- Other Information
- QUESTIONS
- SPL UNCLASSIFIED SECTION
- Packaging
-
INGREDIENTS AND APPEARANCE
CALFARME FOAM CARE
benzalkonium chloride liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70136-101 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE 20 g in 1 L Inactive Ingredients Ingredient Name Strength COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) COCO GLUCOSIDE (UNII: ICS790225B) POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600000 MW) (UNII: 0L414VCS5Y) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70136-101-04 4 in 1 CARTON 10/06/2015 1 3.78 L in 1 CAN; Type 0: Not a Combination Product 2 NDC:70136-101-02 16 in 1 CARTON 10/06/2015 2 1.89 L in 1 CAN; Type 0: Not a Combination Product 3 NDC:70136-101-01 12 in 1 CARTON 10/06/2015 3 0.945 L in 1 CAN; 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 10/06/2015 Labeler - Calfarme (singapore) Pte.Ltd (595222746) Establishment Name Address ID/FEI Business Operations Calfarme (singapore) Pte.Ltd 595222746 manufacture(70136-101)