Label: CALFARME FOAM CARE- benzalkonium chloride liquid
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- 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 25, 2018
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- Drug Facts
- Active Ingredient
- Purpose
- KEEP OUT OF REACH OF CHILDREN
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Close - Uses
- 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
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■ irritation or redness develops
■ condition persists for more than 72 hours. - Directions
■ dilute 1 part FOAM CARE CONCENTRATE to 20 parts with Distilled water (50ml to 1,000ml with Distilled water).
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■ formulated for used with manual or NO-TOUCH automatic foam pump dispenser.
■ pump a small amount of foam onto palm
■ rub and clean the hands well before rinse with water. - INACTIVE INGREDIENT
Inactive Ingredients Cocoamidopropylbetaine, Coco fatty acid diethanolamide, Fragrance, Sodium laureth sulfate, Water.
Close - Other Information
■ keep the container closed when not in use.
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■ keep only in the original container in a cool, well ventilated place away from direct sunlight & heat sources. - QUESTIONS
- SPL UNCLASSIFIED SECTION
MANUFACTURED BY CALFARME (SINGAPORE) PTE LTD
ISO 9001:2008 & ISO 14001:2004 Certified
AMK TechLink, 20 Ang Mo Kio Industrial Park 2A #06-18
Singapore 567761
DISTRIBUTED BY CALFARME US INC.11311 White Rock Road, Rancho Cordova, CA 95742
MADE IN SINGAPORE
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- 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 DIETHANOLAMIDE (UNII: 92005F972D) SODIUM LAURETH-3 SULFATE (UNII: BPV390UAP0) 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) CloseEstablishment Name Address ID/FEI Business Operations Calfarme (singapore) Pte.Ltd 595222746 manufacture(70136-101)
