Label: AMULDY S- glycerin liquid
- NDC Code(s): 82145-0001-1
- Packager: Aloe Vera Korea Co.,Ltd.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not 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.
Drug Label Information
Updated July 29, 2021
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- INACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
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WARNINGS
■ if following abnormal symptoms occurs after use , stop use and consult with a skin specialist
red specks, swelling, itching
■ don’t use on the part where there is injury, eczema, or dermatitis
Keep out of reach of children
■ if swallowed, get medical help or contact a person control center immediately
- DOSAGE & ADMINISTRATION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
AMULDY S
glycerin liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:82145-0001 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN 8 g in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) ALLANTOIN (UNII: 344S277G0Z) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:82145-0001-1 50 mL in 1 BOTTLE; Type 0: Not a Combination Product 08/04/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part347 08/04/2021 Labeler - Aloe Vera Korea Co.,Ltd. (687773350) Registrant - Aloe Vera Korea Co.,Ltd. (687773350) Establishment Name Address ID/FEI Business Operations Aloe Vera Korea Co.,Ltd. 687773350 manufacture(82145-0001)
