NO MORE PRODUCTS- glycerin, kaolin, calamine, menthol cream

No More Products by

Drug Labeling and Warnings

No More Products by is a Otc medication manufactured, distributed, or labeled by Sarati International, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active Ingredients

Glycerin      25%
Kaolin        12.5%
Calamine   12.5%
Menthol        1%

PURPOSE

Purposes

Glycerin ....................................................Protectant
Kaolin .........................................Protectant/Anti-Itch
Calamine ....................................Protectant/Anti-Itch
Menthol .....................................................Analgesic

INDICATIONS & USAGE

Uses Helps relieve the itching and discomfort associated with anorectal disorders
Provides temporary relief from the symptoms of perianal skin irritation For the temporary
relief of itching associated with moist anorectal conditions For the temporary relief of
irritation and burning

WARNINGS

Warnings
For rectal use only
Do not useunless a prior doctor’s diagnosis of anorectal condition has been made
When using this productdo not exceed the recommended daily dosage unless directed by a doctor
Stop use and ask a doctor if bleeding occurs condition worsens or does not improve within 7 days
allergic reaction develops symptoms being treated do not subside or if redness, irritation, swelling, pain,
other symptoms develop or increase Do not put this product into the rectum by using fingers or any
mechanical device or applicator. Remove petrolatum or greasy ointment before using this product
because they interfere with the ability of this product to adhere properly to the skin area.
If pregnant or breastfeeding, ask a health professional before use

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

DOSAGE & ADMINISTRATION

Directions
Adults: When practical, cleanse the affected area by patting or blotting with an appropriate cleansing wipe.
Gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product.
Apply a pea sizeamount of cream externallyto the anal area and to the inner rim of the anus,
not deep into the rectum. Children under 12 years of age: consult a doctor Apply externally to the
affected area once or twice daily when pain or irritation is present.

OTHER SAFETY INFORMATION

Other Information:Do not use if tube seal is cut, broken or missing.  store at 15-30º C (59-86º F)

INACTIVE INGREDIENT

Inactive Ingredients:Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Cetearyl Alcohol, Deionized Water,
Dimethicone/Vinyl Dimethicone Crosspolymer, Isopropyl Palmitate, Magnesium Aluminum Silicate,
Phenoxyethanol, Polysorbate 20, Propylene Glycol, SD Alcohol, Silica, Stearyl Alcohol

QUESTIONS

Questions or Comments?Email: Admin@NoMoreProducts.com

No More Product Labeling

No More Products

Net Wt. 1.25oz (35g)

Manufactured by Sarati Intn'i, 27502 Ted Hunt Rd., Los Fresnos TX  78566

www.nomoreproducts.com

No More Fissure Box

No More Fissure Tube

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No More Hemorrhoids Tube

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No More Pruritus Tube

RES

INGREDIENTS AND APPEARANCE

NO MORE PRODUCTS 
glycerin, kaolin, calamine, menthol cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67676-008
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX)	GLYCERIN	25 g  in 100 g
KAOLIN (UNII: 24H4NWX5CO) (KAOLIN - UNII:24H4NWX5CO)	KAOLIN	12.5 g  in 100 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	12.5 g  in 100 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	1 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
WATER (UNII: 059QF0KO0R)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
ALCOHOL (UNII: 3K9958V90M)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67676-008-01	1 in 1 BOX	03/01/2023
1		21 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 Drug	M015	03/01/2023

Labeler - Sarati International, Inc (160219770)

Registrant - Sarati International, Inc (160219770)

Establishment
Name	Address	ID/FEI	Business Operations
Sarati International, Inc		160219770	manufacture(67676-008) , pack(67676-008)