Keeper Medal: Package Insert and Label Information

KEEPER MEDAL- mineral oil liquid
AML Bio Co., Ltd.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

mineral complex

antiseptic

KEEP OUT OF REACH OF THE CHILDREN

apply proper amount to the subject area

■ For external use only.

■ Do not use in eyes.

■ lf swallowed, get medical help promptly.

■ Stop use, ask doctor lf irritation occurs.

■ Keep out of reach of children.

for external use only

Water

label
(click image for full-size original)

KEEPER MEDAL
mineral liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:81016-0001
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MINERAL OIL (MINERAL OIL) MINERAL OIL 100 g in 100 mL
Inactive Ingredients
Ingredient Name Strength
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:81016-0001-1 500 mL in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 11/09/2020
Labeler — AML Bio Co., Ltd. (695067521)
Registrant — AML Bio Co., Ltd. (695067521)
Establishment
Name Address ID/FEI Operations
AML Bio Co., Ltd. 695067521 manufacture (81016-0001)

Revised: 02/2022 AML Bio Co., Ltd.

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