Label: WELLSTAR AMENITY- benzalkonium chloride and sodium monofluorophosphate kit
- NDC Code(s): 42555-060-45, 59448-008-01, 59448-800-00
- Packager: ASP Global, LLc
- 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 December 16, 2022
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active Ingredient
- Purpose
- Uses
- Warnings
- Directions
- Other Information
- Inactive Ingredients
- SPL UNCLASSIFIED SECTION
- SPL UNCLASSIFIED SECTION
- Active ingredient
- Purpose
- Use
- Warnings
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Directions
adults and children 2 years of age and older brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physician children 2 to 6 years use only a pea sized amount and supervise child's brushing and rinsing (to minimize swallowing) children under 2 years ask a dentist or physician - Inactive ingredients
- Questions or comments?
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 53 mL Bottle Label
- PRINCIPAL DISPLAY PANEL - 10 g Tube Label
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PRINCIPAL DISPLAY PANEL - Kit Label
Wellstar
Item #: WSHKIT02
Description: AMENITY KIT, WELLSTAR
PO #:
Lot #: XMMDDFC
Exp: YYYY-MM-DD
Qty: 20 KIT/CS
Carton #: XXX of XXXX
Net Wt.: XX KG
Gross Wt.: XX KG
Cubic Dimensions: 65.0 x 20.0 x 33.0 CMAssembled in China
Components Made in China:
- Hand Sanitizer
- Alcohol-Free Mouthwash
- Lip Balm
- Toothbrush
- Hairbrush
- Body Lotion
- Body Wash
- Shampoo/Conditioner
- Deodorant Stick
- Facial Tissue
- Nail File
- Pen
- Notepad
- Kit Case
Component Made in Thailand:
- Toothpaste
WSHKIT02-MC-00
Wellstar
Contents/Origins:
2.0 fl. oz. Shampoo/Conditioner
2.0 fl. oz. Body Wash
2.0 fl. oz. Body Lotion
2.0 fl. oz. Alcohol-Free Mouthwash
0.15 oz. net wt. Lip Balm
0.5 oz. net wt. Deodorant Stick
1.9 fl. oz. Hand SanitizerToothbrush, Hairbrush, Facial Tissue, Nail File, Pen, Notepad,
and Kit Case: Made in China
Toothpaste: Made in ThailandLot #:
Exp:Distributed by:
ASP Global, LLC
7800 Third Flag Parkway, Austell, GA 30168, USAREV 00
Wellstar
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INGREDIENTS AND APPEARANCE
WELLSTAR AMENITY
benzalkonium chloride and sodium monofluorophosphate kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:59448-800 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:59448-800-00 20 in 1 BOX 10/01/2021 1 1 in 1 BAG Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 BOTTLE, PLASTIC 53 mL Part 2 1 TUBE 10 g Part 3 1 TUBE 59 mL Part 4 1 TUBE 59 mL Part 5 1 TUBE 59 mL Part 6 1 TUBE 4.25 g Part 7 1 BOTTLE, PLASTIC 65 mL Part 8 1 BOTTLE, WITH APPLICATOR 14 g Part 1 of 8 INSTANT HAND ANTISEPTIC
alcohol gelProduct Information Item Code (Source) NDC:59448-008 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Alcohol (UNII: 3K9958V90M) (Alcohol - UNII:3K9958V90M) Alcohol 62 mL in 100 mL Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) Aloe Vera Leaf (UNII: ZY81Z83H0X) Glycerin (UNII: PDC6A3C0OX) Propylene Glycol (UNII: 6DC9Q167V3) CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO) Trolamine (UNII: 9O3K93S3TK) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:59448-008-01 53 mL in 1 BOTTLE, PLASTIC; 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 part333E 10/01/2021 Part 2 of 8 COLGATE ANTICAVITY
sodium monofluorophosphate paste, dentifriceProduct Information Item Code (Source) NDC:42555-060 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Sodium Monofluorophosphate (UNII: C810JCZ56Q) (Fluoride Ion - UNII:Q80VPU408O) Fluoride Ion 7.6 mg in 1 g Inactive Ingredients Ingredient Name Strength Dibasic Calcium Phosphate Dihydrate (UNII: O7TSZ97GEP) Water (UNII: 059QF0KO0R) Sorbitol (UNII: 506T60A25R) Sodium Lauryl Sulfate (UNII: 368GB5141J) Sodium Pyrophosphate (UNII: O352864B8Z) Saccharin Sodium (UNII: SB8ZUX40TY) Product Characteristics Color WHITE Score Shape Size Flavor MINT Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:42555-060-45 10 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part355 06/04/2009 Part 3 of 8 GILCHRIST AND SOAMES BODY BUTTER--LOTION
cleansing (cold creams, cleansing lotions, liquids, and pads)Product Information Other Ingredients Ingredient Kind Ingredient Name Quantity INGR Water (UNII: 059QF0KO0R) INGR ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M) INGR CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) INGR GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) INGR CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) INGR ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) INGR BENZYL ALCOHOL (UNII: LKG8494WBH) INGR PEG-100 STEARATE (UNII: YD01N1999R) INGR CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E) INGR DEHYDROACETIC ACID (UNII: 2KAG279R6R) INGR SODIUM HYDROXIDE (UNII: 55X04QC32I) Product Characteristics color WHITE C48325 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 59 mL in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Cosmetic 07/01/2013 Part 4 of 8 GILCHRIST AND SOAMES HAIR 2 IN 1--SHAMPOO-CONDITIONER
shampoos (non-coloring)Product Information Other Ingredients Ingredient Kind Ingredient Name Quantity INGR Water (UNII: 059QF0KO0R) INGR SODIUM LAURETH-3 SULFATE (UNII: BPV390UAP0) INGR SODIUM CHLORIDE (UNII: 451W47IQ8X) INGR GLYCERIN (UNII: PDC6A3C0OX) INGR COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) INGR COCO MONOETHANOLAMIDE (UNII: C80684146D) INGR POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 2600000 MW) (UNII: U1G23TFV1K) INGR CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) INGR MAGNESIUM NITRATE (UNII: 77CBG3UN78) INGR METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN) INGR MAGNESIUM CHLORIDE (UNII: 02F3473H9O) INGR METHYLPARABEN (UNII: A2I8C7HI9T) INGR PROPYLPARABEN (UNII: Z8IX2SC1OH) INGR METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA) INGR FD&C YELLOW NO. 5 (UNII: I753WB2F1M) INGR FD&C RED NO. 4 (UNII: X3W0AM1JLX) Product Characteristics color YELLOW C48330 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 59 mL in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Cosmetic 07/01/2013 Part 5 of 8 GILCHRIST AND SOAMES BODY REFRESHER--BODY WASH
skin freshenersProduct Information Other Ingredients Ingredient Kind Ingredient Name Quantity INGR Water (UNII: 059QF0KO0R) INGR SODIUM LAURETH-3 SULFATE (UNII: BPV390UAP0) INGR SODIUM CHLORIDE (UNII: 451W47IQ8X) INGR COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) INGR GLYCERIN (UNII: PDC6A3C0OX) INGR POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 2600000 MW) (UNII: U1G23TFV1K) INGR COCO MONOETHANOLAMIDE (UNII: C80684146D) INGR MAGNESIUM NITRATE (UNII: 77CBG3UN78) INGR CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) INGR METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN) INGR MAGNESIUM CHLORIDE (UNII: 02F3473H9O) INGR METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA) INGR FD&C YELLOW NO. 5 (UNII: I753WB2F1M) INGR FD&C RED NO. 4 (UNII: X3W0AM1JLX) INGR FD&C BLUE NO. 1 (UNII: H3R47K3TBD) Product Characteristics color WHITE C48325 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 59 mL in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Cosmetic 11/01/2016 Part 6 of 8 WELLSTAR LIP BALM
lipstickProduct Information Other Ingredients Ingredient Kind Ingredient Name Quantity INGR ETHYLHEXYL PALMITATE (UNII: 2865993309) INGR MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) INGR POLYISOBUTYLENE (2300 MW) (UNII: DSQ2V1DD1K) INGR YELLOW WAX (UNII: 2ZA36H0S2V) INGR HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7) INGR SHEANUT OIL (UNII: O88E196QRF) INGR .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) INGR PHENOXYETHANOL (UNII: HIE492ZZ3T) Product Characteristics color YELLOW C48330 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 4.25 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Cosmetic 06/13/2018 Part 7 of 8 ASP GLOBAL ALCOHOL-FREE MOUTHWASH
mouthwashes and breath fresheners (liquids and sprays)Product Information Other Ingredients Ingredient Kind Ingredient Name Quantity INGR Water (UNII: 059QF0KO0R) INGR GLYCERIN (UNII: PDC6A3C0OX) INGR POLYSORBATE 20 (UNII: 7T1F30V5YH) INGR SODIUM BENZOATE (UNII: OJ245FE5EU) INGR MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) INGR SACCHARIN SODIUM (UNII: SB8ZUX40TY) INGR CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P) INGR FD&C BLUE NO. 1 (UNII: H3R47K3TBD) Product Characteristics color BLUE C48333 flavor MINT C73404 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 65 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Cosmetic 06/13/2018 Part 8 of 8 GILCHRIST AND SOAMES DEODORANT
deodorants (underarm)Product Information Other Ingredients Ingredient Kind Ingredient Name Quantity INGR Water (UNII: 059QF0KO0R) INGR GLYCERIN (UNII: PDC6A3C0OX) INGR Polyethylene Glycol 400 (UNII: B697894SGQ) INGR Stearic Acid (UNII: 4ELV7Z65AP) INGR Polysorbate 20 (UNII: 7T1F30V5YH) INGR Sodium Hydroxide (UNII: 55X04QC32I) INGR WHITE WAX (UNII: 7G1J5DA97F) INGR Starch, Rice (UNII: 4DGK8B7I3S) INGR Lavender Oil (UNII: ZBP1YXW0H8) INGR Tannic Acid (UNII: 28F9E0DJY6) INGR Sodium Lactate (UNII: TU7HW0W0QT) INGR Butylene Glycol (UNII: 3XUS85K0RA) INGR PHENOXYETHANOL (UNII: HIE492ZZ3T) INGR Benzyl Alcohol (UNII: LKG8494WBH) INGR Coumarin (UNII: A4VZ22K1WT) INGR LINALOOL, (+/-)- (UNII: D81QY6I88E) INGR LIMONENE, (+)- (UNII: GFD7C86Q1W) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 14 g in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Cosmetic 10/24/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333E 10/01/2021 Labeler - ASP Global, LLc (080361159) Establishment Name Address ID/FEI Business Operations Shengzhou Kingbird Travel Products Co., Ltd. 560219293 PACK(59448-800) , LABEL(59448-800) Establishment Name Address ID/FEI Business Operations Colgate-Palmolive (Thailand) LTD 672044552 MANUFACTURE(59448-800) Establishment Name Address ID/FEI Business Operations Nantong Health & Beyond Hygienic Products Inc. 421280161 MANUFACTURE(59448-800)