OTC Medication Information: Wakaya RuRu Topical Analgesic

WAKAYA RURU TOPICAL ANALGESIC- menthol cream
I Shay Cosmetics Inc

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.

Active Ingredient

Menthol 1.25%………………… Topical Analgesic

For the temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises, and sprains.

Keep Out of Reach of Children.

If pregnant or breast-feeding, ask a health professional before use.

If swallowed get medical help or contact poisoncontrol center right away.

Inactive Ingredients

Water

Cetylated Fatty Acids (Myristoleate, Myristate, Laurate, Palmitate, and Oleate)

Stearic Acid

Glyceryl Stearate

Glycerin

Benzyl Alcohol

Mentha Piperita (Peppermint Oil)

Lecithin

Phenoxyethanol

Sodium Hydroxide

Carbomer

Tocopheryl Acetate

Warnings

For external use only.

Avoid contact with eyes.

If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of product and consult a physician.

Do not bandage tightly

DIRECTIONS

Adults ands children 2 years of age and older: Apply to affected area not more than 3 to 4 times per day. Children under 2 years of age: Consult a physician

Other Information

Store in a cool, dry place.

For the temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises, and sprains.

label

label
(click image for full-size original)

WAKAYA RURU TOPICAL ANALGESIC
external analgesic cream
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:65112-265
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MENTHOL (MENTHOL) MENTHOL 1.25 g in 100 g
Inactive Ingredients
Ingredient Name Strength
WATER 75 g in 100 g
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:65112-265-01 71 g in 1 BOTTLE, PUMP None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part348 01/13/2021
Labeler — I Shay Cosmetics Inc (151582384)

Revised: 01/2021 I Shay Cosmetics Inc

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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