Label: HEMORRHOID RELIEF CREAM- lidocaine 5% anorectal cream
- NDC Code(s): 73492-712-28
- Packager: ALAINA HEALTHCARE PRIVATE LIMITED
- 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 January 28, 2022
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- Drug Facts Active Ingredient
For external use only
When using this product
- use only as directed.
- Avoid contact with eyes.
- do not exceed recommended dosage unless directed by a doctor.
- do not out this product into the rectum by using fingers or any mechanical device or applicator.
Stop use and ask a doctor if
- rectal bleeding occurs.
- condition worsens or does not improve within 7 days.
- symptoms clear up and occur again within a few days.
- an allergic reaction develops to ingredients in this product.
- symptom being treated does not subside or if redness, irritation, swelling, pain or other symptoms develop or increase.
If pregnant or breast-feeding, ask a health professional before use.
- KEEP OUT OF REACH OF CHILDREN
Adult and children 12 years and over:
- When practical, cleanse the affected area with mild soap and warm water and rinse thoroughly, gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product.
- apply externally to the affected area up to 6 times a day children under 12 years of age: consult a doctor.
- Other Information.
- Inactive Ingredient
- Questions or Comments? 1-888-287-1915
SPL UNCLASSIFIED SECTION
Alaina Healthcare Private Limited
Khasra No. 127-133, Baddi-Barotiwala Road,
Baddi, HIMACHAL PRADESH 173205, India (IND).
Walmart Inc., Bentonville, AR 72716. PRODUCT OF INDIA.
*This product is not manufactured or distributed by Ferndale IP, Inc., Owner of the registered trademark RectiCare ®.
- Package Label.Principal Display Panel
INGREDIENTS AND APPEARANCE
HEMORRHOID RELIEF CREAM
lidocaine 5% anorectal cream
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:73492-712 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE 50 mg in 1 g Inactive Ingredients Ingredient Name Strength BENZYL ALCOHOL (UNII: LKG8494WBH) CARBOMER 940 (UNII: 4Q93RCW27E) CHOLESTEROL (UNII: 97C5T2UQ7J) ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) POLYSORBATE 80 (UNII: 6OZP39ZG8H) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) TROLAMINE (UNII: 9O3K93S3TK) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:73492-712-28 1 in 1 CARTON 01/28/2022 1 28 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 part346 01/28/2022 Labeler - ALAINA HEALTHCARE PRIVATE LIMITED (858720927) Establishment Name Address ID/FEI Business Operations ALAINA HEALTHCARE PRIVATE LIMITED 858720927 manufacture(73492-712)