Label: PRANICURA- glycerin, kaolin, calamine, menthol cream
- NDC Code(s): 71831-002-01, 71831-002-03
- Packager: Pranicura, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Updated December 8, 2020
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- Drug Facts
- INDICATIONS & USAGE
- DO NOT USE
- WHEN USING
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
• 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
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
DOSAGE & ADMINISTRATION
• 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.
• For Pruritus Ani: Wait 20 seconds after drying. If the desire to scratch is gone, do not
apply cream. If the desire to scratch continues, apply a fingertip amount of ointment to
anal and perianal areas. Use finger cot or disposable gloves if desired. Rub or lightly
scratch (with fingertip, not fingernails) until the itch is satisfied.
• For Anal Fissures: Apply a fingertip amount of cream to the anal area and to the inner
rim of the anus.
• Children under 12 years of age: consult a doctor
• Apply externally to the affected area once or twice daily when pain or irritation from
anal fissures are present or ideally after bowel movement.
- OTHER SAFETY INFORMATION
- INACTIVE INGREDIENT
- Principal Display Package
INGREDIENTS AND APPEARANCE
glycerin, kaolin, calamine, menthol cream
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71831-002 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 COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) WATER (UNII: 059QF0KO0R) ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M) PHENOXYETHANOL (UNII: HIE492ZZ3T) POLYSORBATE 20 (UNII: 7T1F30V5YH) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) ALCOHOL (UNII: 3K9958V90M) STEARYL ALCOHOL (UNII: 2KR89I4H1Y) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71831-002-01 70 g in 1 JAR; Type 0: Not a Combination Product 01/31/2019 2 NDC:71831-002-03 56 g in 1 JAR; Type 0: Not a Combination Product 01/31/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part346 01/01/2019 Labeler - Pranicura, LLC (080842423) Registrant - Pranicura, LLC (080842423) Establishment Name Address ID/FEI Business Operations Sarati International, Inc. 160219770 manufacture(71831-002)