CONTRAINDICATIONS
None known.
WARNINGS
Use of this product should be discontinued if hypersensitivity to any of the ingredients is noted. Sun
exposure (natural or artificial sunlight) to areas of the skin treated with ammonium lactate cream
should be minimized or avoided (see PRECAUTIONS).
PRECAUTIONS
General
For external use only. Stinging or burning may occur when applied to skin with fissures, erosions, or
that is otherwise abraded (for example, after shaving the legs). Caution is advised when used on the
face because of the potential for irritation. The potential for post-inflammatory hypo- or
hyperpigmentation has not been studied.
Information for the Patient
Patients using ammonium lactate cream should receive the following information and instructions:
1. This medication is to be used as directed by the physician, and should not be used for any
disorder other than for which it was prescribed. Caution is advised when used on the face
because of the potential for irritation. It is for external use only. Avoid contact with eyes, lips,
or mucous membranes.
2. Patients should minimize or avoid use of this product on areas of the skin that may be
exposed to natural or artificial sunlight, including the face. If sun exposure is unavoidable,
clothing should be worn to protect the skin.
3. This medication may cause stinging or burning when applied to skin with fissures, erosions,
or abrasions (for example, after shaving the legs).
4. If the skin condition worsens with treatment, the medication should be promptly
discontinued.
Carcinogenesis, Mutagenesis, and Impairment of Fertility
A long-term photocarcinogenicity study in hairless albino mice suggested that topically applied 12%
ammonium lactate cream enhanced the rate of ultraviolet light-induced skin tumor formation.
Although the biologic significance of these results to humans is not clear, patients should minimize or
avoid use of this product on areas of the skin that may be exposed to natural or artificial sunlight,
including the face. Long-term dermal carcinogenicity studies in animals have not been conducted to
evaluate the carcinogenic potential of ammonium lactate.
Pregnancy, Teratogenic Effects, Pregnancy Category C
Animal reproduction studies have not been conducted with ammonium lactate cream. It is also not
known whether ammonium lactate cream can cause fetal harm when administered to a pregnant
woman or can affect reproduction capacity. Ammonium lactate cream should be given to a
pregnant woman only if clearly needed.
Nursing Mothers
Although lactic acid is a normal constituent of blood and tissues, it is not known to what extent this
drug affects normal lactic acid levels in human milk. Because many drugs are excreted in human
milk, caution should be exercised when ammonium lactate cream is administered to a nursing
woman.
Pediatric Use
The safety and effectiveness of ammonium lactate cream have not been established in pediatric
patients less than 12 years old. Potential systemic toxicity from percutaneous absorption has not
been studied. Because of the increased surface area to body weight ratio in pediatric patients, the
systemic burden of lactic acid may be increased.