SLOW CORPORATION- toothpaste, sodium monofluorophosphate paste

Slow Corporation by

Drug Labeling and Warnings

Slow Corporation by is a Otc medication manufactured, distributed, or labeled by Integrity12 Inc, Sangleaf Pharm Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Sodium Monofluorophosphate 0.76%

Use

Helps protect against cavities

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children under 6 years of age.

INDICATIONS & USAGE

Directions:

Adult 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.

WARNINGS

If more than used for brushing is accidentally swalloed, get medical help or contact a Poison Control Center right away.

INACTIVE INGREDIENT

Sorbitol, purified water, Hydrated silica, Glycerin, Xylitol, Xanthan gum, Sodium Cocoyl Glutamate, Stevia Rebaudiana Extract, Cocos Nucifera (Coconut) Oil, Cellulose Gum, Menthol, Mentha Spicata Herb Oil, Rosmarinus Offiicinalis (Rosemary) Extract, Centella Asiatica Extract, Scutellaria Baicalensis Root Extract, Camellia Sinensis Leaf Extract, Calendula Officinalis Flower Extract, Glycyrrhiza Glabra (Licorice) Root Extract, Chamomilla Recutita (Matricaria) Extract, Charcoal Powder, Cannabis Sativa (Hemp) Seed Oil

DOSAGE & ADMINISTRATION

Paste pea size of toothpaste on the tooth brush

PRINCIPAL DISPLAY PANEL

250g; NDC: 81111-100-01

INGREDIENTS AND APPEARANCE

SLOW CORPORATION 
toothpaste, sodium monofluorophosphate paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81111-100
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.76 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
STEVIA REBAUDIANA WHOLE (UNII: 6U422Y08O2)
XANTHAN GUM (UNII: TTV12P4NEE)
COCONUT OIL (UNII: Q9L0O73W7L)
XYLITOL (UNII: VCQ006KQ1E)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
GLYCERIN (UNII: PDC6A3C0OX)
CARBOXYMETHYLCELLULOSE SODIUM (0.7 CARBOXYMETHYL SUBSTITUTION PER SACCHARIDE; 1200 MPA.S AT 1%) (UNII: 4J4P6L645M)
SODIUM COCOYL GLUTAMATE (UNII: BMT4RCZ3HG)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
MENTHOL (UNII: L7T10EIP3A)
SORBITOL (UNII: 506T60A25R)
SPEARMINT OIL (UNII: C3M81465G5)
ACTIVATED CHARCOAL (UNII: 2P3VWU3H10)
CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)
CENTELLA ASIATICA (UNII: 7M867G6T1U)
SCUTELLARIA BAICALENSIS ROOT (UNII: 7J95K7ID2S)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)
MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 81111-100-01	250 g in 1 BOTTLE; Type 0: Not a Combination Product	11/20/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	11/20/2020

Labeler - Integrity12 Inc (695586794)

Establishment
Name	Address	ID/FEI	Business Operations
Sangleaf Pharm Co., Ltd.		689847343	manufacture(81111-100)