MINERAL OIL- mineral oil enema 
Dynarex Corporation

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.

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Enema, Mineral Oil

Active Ingredient                            Purpose

Mineral Oil, 100%                    Lubricant Laxative            

Uses:

Warnings:

For rectal use only



As a doctor before use if you have:


Stop use and ask a doctor if:

Keep out of reach of children

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Other information:

Directions

Single daily dose

Adults and children 12 years and older - 1 bottle

Children 2 to under 12 years - 1/2 bottle

Children under 2 years - Do not use. Consult a physician.


How to use this enema:

REMOVE GREEN PROTECTIVE SHIELD BEFORE INSERTING.

Hold bottle upright, grasping bottle cap with fingers. Grasp protective shield with the other hand and pull gently to remove.

See image on box

Positioning

Left-side position: Lie on left side with knee bent and arms at rest.

See image on box

Knee-chest position: Kneel, then lower head and chest forward until the left side of face is resting on surface. Position arms comfortably.

See image on box

Administering Enema

Principal Display Panel

Mineral oil enema.jpg

Mineral oil enema

MINERAL OIL 
mineral oil enema
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:67777-401
Route of AdministrationRECTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MINERAL OIL (MINERAL OIL) MINERAL OIL118 mg  in 118 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:67777-401-0148 in 1 CASE
11 in 1 BOX
1118 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33408/29/2012
Labeler - Dynarex Corporation (008124539)
Registrant - Dynarex Corporation (008124539)
Establishment
NameAddressID/FEIBusiness Operations
Galentic Pharma (India) Pvt. Ltd.864201135manufacture(67777-401)

Revised: 2/2013
Document Id: 23a57e7f-1318-42e3-ba0b-7a1849000cf4
Set id: 141ff82f-ba4c-4646-8544-2350d4f85563
Version: 3
Effective Time: 20130228
 
Dynarex Corporation