Label: MEDI HYDRO DP- glycerin emulsion
-
Contains inactivated NDC Code(s)
NDC Code(s): 70694-0007-1 - Packager: Inc MBG
- 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 January 24, 2019
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- INDICATIONS & USAGE
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
-
WARNINGS
Discontinue use of the product if any of the following symptoms occurred. Consult a dermatologist if the symptoms got worse.
a) If redness, Swelling, Itchiness, Irritation occurred during using.
b) If the above symptoms started to occur when exposed to direct sunlight.
Do not use on skins with wounds, eczema or dermatitis.Storage instructions
a) Always close the lid after finish using.
b) Store in a safe place away and out of reach of children.
c) Store in a place with not too high or low temperature, keep awayfrom direct sunlight exposure. - PURPOSE
- INACTIVE INGREDIENT
- ACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
MEDI HYDRO DP
glycerin emulsionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70694-0007 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN 6 g in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70694-0007-1 130 mL in 1 BOTTLE; Type 0: Not a Combination Product 01/24/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part347 01/24/2019 Labeler - Inc MBG (688436167) Establishment Name Address ID/FEI Business Operations Inc MBG 688436167 manufacture(70694-0007)