Label: 4718 ENEMA, MINERAL OIL enema
- NDC Code(s): 67777-430-01
- Packager: Dynarex
- 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.
Updated February 23, 2021
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- Active Ingredient
For rectal use only.
Do not use
- Laxative products when abdominal pain, nausea or vomiting are present unless directed by a doctor.
- Longer than one week unless directed by a doctor.
Ask a doctor before use if you have
- Noticed a sudden change in bowel habits that persists over a period of two weeks.
- Other information
INGREDIENTS AND APPEARANCE
4718 ENEMA, MINERAL OIL
4718 enema, mineral oil enema
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:67777-430 Route of Administration RECTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MINERAL OIL (UNII: T5L8T28FGP) (MINERAL OIL - UNII:T5L8T28FGP) MINERAL OIL 100 g in 118 g Product Characteristics Color Score Shape FREEFORM Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:67777-430-01 48 in 1 CASE 02/26/2021 1 1 in 1 BOX 1 118 g in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part334 02/26/2021 Labeler - Dynarex (008124539)